[Federal Register Volume 63, Number 69 (Friday, April 10, 1998)]
[Proposed Rules]
[Pages 17744-17771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9486]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 26

[Docket No. 95N-0185]
RIN 0910-ZA11


Mutual Recognition of the Food and Drug Administration and 
European Community Member State Conformity Assessment Procedures; 
Pharmaceutical GMP Inspection Reports, Medical Device Quality System 
Evaluation Reports, and Certain Medical Device Premarket Evaluation 
Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations pursuant to an international agreement that is expected 
to be concluded between the United States and the European Community 
(EC) (Ref. 1). Under the terms of that agreement, FDA may normally 
endorse good manufacturing practice (GMP) inspection reports for 
pharmaceuticals provided by equivalent EC Member State regulatory 
authorities and medical device quality system evaluation reports and 
certain medical device premarket evaluation reports provided by 
equivalent conformity assessment bodies. FDA is taking this action to 
enhance its ability to ensure the safety and efficacy of 
pharmaceuticals and medical devices through more efficient and 
effective utilization of its regulatory resources. The agency is 
requesting comments on the proposed rule.

DATES: Comments by May 11, 1998. Comments must be received by the 
Dockets Management Branch (address below) by 4:30 p.m. Eastern Standard 
Time on May 11, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857, fax 301-594-3215.

FOR FURTHER INFORMATION CONTACT: Merton V. Smith, Office of 
International Affairs (HFG-1), Office of External Affairs, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
0910, or E-mail: ``MS[email protected]''.

SUPPLEMENTARY INFORMATION:

I. Background and History

    On June 20, 1997, the United States and the EC concluded 
negotiations of an agreement entitled ``Agreement on Mutual Recognition 
between the United States of America and the European Community'' (also 
called ``the MRA''). The MRA includes two sectoral annexes covering 
products regulated by FDA. The medical device sectoral annex covers 
medical device quality system-related inspection reports and premarket 
evaluation reports. The pharmaceutical GMP sectoral annex covers 
pharmaceutical GMP inspection reports. The MRA also includes sectoral 
annexes covering products regulated by other U.S. regulatory agencies, 
including telecommunication equipment, electromagnetic compatibility, 
electrical safety, and recreational craft. Finally, the MRA includes an 
``umbrella'' agreement that contains general provisions applicable

[[Page 17745]]

to the operation of all of the sectoral annexes.
    At the conclusion of negotiations, the United States and the EC 
agreed to submit the text of the MRA to their respective authorities to 
complete the necessary procedures for approval and implementation (Ref. 
2). For FDA, the procedures include publishing this proposed rule for 
public comment.
    In this document, FDA has published relevant provisions of the two 
FDA sectoral annexes and the umbrella agreement, some of which create 
binding obligations. FDA will review all comments and will consider 
those comments addressing its binding obligations under the agreement.

II. Statutory Authority

    FDA has the authority to enter into and execute the MRA under the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 et seq.) 
and the Public Health Service Act (the PHS Act) (42 U.S.C. 201 et 
seq.). For drugs and medical devices, section 510(i)(3) of the act (21 
U.S.C. 360(i)(3)) provides authority for FDA to enter into the MRA. 
Section 510(i)(3) of the act provides that:
    The Secretary [FDA by delegation] is authorized to enter into 
cooperative arrangements with officials of foreign countries to 
ensure that adequate and effective means are available for purposes 
of determining, from time to time, whether drugs or devices 
manufactured, prepared, propagated, compounded, or processed by an 
establishment * * * [described in this section], if imported or 
offered for import into the United States, shall be refused 
admission on any of the grounds set forth in section 801(a).
(Ref. 3).
    The MRA and the pharmaceutical and medical device annexes represent 
cooperative arrangements with officials from foreign countries. The 
purpose of these arrangements is, among other things, to ensure FDA has 
adequate and effective means to determine whether drugs or devices 
offered for import are adulterated, misbranded, or in violation of 
section 505 of the act (21 U.S.C. 355) (Ref. 4). FDA's authority to 
make these determinations is found at section 801(a) of the act (21 
U.S.C. 381(a)).
    Section 803(b) of the act (21 U.S.C. 383(b)) provides FDA with 
authority to enter into the medical device sectoral annex. That section 
authorizes FDA to enter into agreements with foreign countries to 
facilitate commerce in medical devices, consistent with the provisions 
of the act. Such agreements are to encourage the mutual recognition of 
GMP regulations relating to devices, as well as other regulations and 
testing protocols determined by the Secretary (FDA by delegation) to be 
appropriate.
    Additional support for FDA authority to enter into this MRA is 
found in the PHS Act. Under section 307 of the PHS Act (42 U.S.C. 
242l), the Secretary of Health and Human Services (FDA by delegation) 
has authority ``to participate with other countries in cooperative 
endeavors'' in biomedical research and health care technology. In 
addition, the Secretary of Health and Human Services (FDA by 
delegation) has authority under section 301 of the PHS Act (42 U.S.C. 
241) to ``cooperate with, and render assistance to other appropriate 
public authorities * * * in the conduct of * * * investigations * * * 
relating to the * * * prevention of physical and mental diseases and 
impairments of man * * * .'' The cooperative activities between FDA and 
the EC set forth in the MRA and this proposed regulation, fall within 
FDA's delegated authority under these sections of the PHS Act.
    Finally, a provision of the recently enacted FDAMA provides 
authority for FDA to participate in MRA activities. Section 410 of 
FDAMA authorizes FDA to ``support the Office of the United States Trade 
Representative, in consultation with the Secretary of Commerce, in 
efforts to move toward the acceptance of mutual recognition agreements 
relating to the regulation of drugs, biological products, [and] devices 
* * * and the regulation of good manufacturing practices, between the 
European Union and the United States'' (Ref. 5). During negotiation of 
this MRA, officials from FDA, the Office of the United States Trade 
Representative, and the Department of Commerce participated in 
activities in an effort to move toward acceptance of a mutual 
recognition agreement.

III. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, under the Regulatory Flexibility Act (Pub. L. 96-354, as 
amended by Pub. L. 104-121), and under the Unfunded Mandates Reform Act 
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The Unfunded Mandates Reform Act requires agencies 
to prepare an assessment of anticipated costs and benefits before 
enacting any rule that may result in an expenditure by State, local and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 (adjusted annually for inflation) in any one year.
    The agency believes that this proposed rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order 
and in these two statutes. Through this regulation, the agency is 
proposing to set out requirements through which it may normally endorse 
certain conformity assessment procedure reports. Such reports would be 
provided by equivalent EC Member State regulatory authorities for 
manufacturing site inspections to ascertain conformity with 
pharmaceutical GMP's and by equivalent conformity assessment bodies for 
quality system audits and certain medical device premarket evaluations. 
Obtaining conformity assessment information in the manner described in 
the proposed rule is inherently more efficient and cost-effective than 
the existing approach, where additional inspection efforts by FDA in 
foreign countries are necessary because foreign regulatory systems have 
not been found equivalent. The primary benefit of the proposed rule is 
to provide credible assurance that the rapidly increasing volume of EC 
Member States' imports into the United States meet pharmaceutical GMP 
requirements, and medical device quality system evaluation and certain 
premarket evaluation requirements, as specified in U.S. statutes and 
regulations. In the future, this credible assurance must be achievable 
without resource expenditures by FDA that are directly proportional to 
the volume of trade.
    In recent years, the credibility of the current approach has been 
strained as FDA's essentially constant foreign inspection capacity has 
been stretched over an expanding volume of imports from the EC. In the 
3-year interval between 1994 and 1997, the value of EC pharmaceutical 
and medical device imports into the United States has nearly doubled 
from $5.5 billion to more than $10.7 billion. Growth has been greatest 
in pharmaceuticals, where

[[Page 17746]]

annual EC exports have increased by more than $2 billion in each of the 
last 2 years. In 1997, FDA conducted one inspection in the EC for every 
$60 million in pharmaceutical exports to the United States, which is 
less than half the coverage intensity of 1994. In addition, the 
majority of these inspections have been preapproval in nature. 
Continuation of the current trend will further decrease FDA's coverage 
intensity to less than one inspection per $100 million in EC 
pharmaceutical exports by the year 2000. Equivalence with EC Member 
State regulatory systems has the potential for leveraging FDA's 
regulatory resources so that necessary conformity assessments can be 
ensured for higher volumes of future trade.
    In addition to coping with higher trade volumes, mutual recognition 
or equivalence-based agreements with exporting nations may permit FDA 
to redirect some of its inspectional resources to risk priorities not 
covered by such agreements. This flexibility would provide a more 
responsive level of U.S. consumer protection in the face of a changing 
global marketplace with inherently variable risk management priorities.
    Another important benefit of the proposed rule would be the cost 
savings realized by the regulated industry, largely as a result of 
sharing inspection reports among equivalent regulatory authorities. 
This exchange, in turn, will eliminate the need for duplicative 
inspections and permit individual firms to undergo fewer inspections of 
manufacturing sites. FDA does not have data on the average 
administrative cost incurred by pharmaceutical (including biological) 
or medical device manufacturers as they participate in regulatory 
inspections, but it is reasonable to assume that the avoidance of 
redundant inspections would generate cost savings. The proposed rule 
also may shorten product review times for regulated products as a 
result of the increased efficiency of premarket approval inspection 
activities and the third-party evaluation of certain medical devices. 
Quantification of this savings will be highly dependent on the specific 
countries that achieve equivalence and the number of medical device 
audits and evaluations performed by conformity assessment bodies.
    The costs of this regulation appear to impact more directly on 
governmental regulatory agencies than on the regulated industry. These 
governmental costs involve both startup and operational components. FDA 
has not received additional government funding earmarked for achieving 
mutual recognition agreements. FDA, therefore, must proceed to 
implement these agreements as a concurrent function within normal day-
to-day regulatory activities. The 3-year transition period reflects the 
necessity to absorb these startup costs within existing regulatory 
budgets. Some activities such as joint inspections may be reasonably 
easy to absorb as concurrent functions that do not require additional 
funding, while others such as developing and maintaining systems for 
routine information exchange may involve new activities. These absorbed 
governmental costs will fall heavily on FDA, as it must assess 
equivalence of multiple EC Member States and notified bodies.
    For FDA, the absorption of these startup costs will be easier with 
respect to those EC Member States with a large volume of trade, where 
FDA already conducts enough inspections to gather a general 
understanding of the requirements and regulatory practices of the 
exporting country. From this perspective, the pace and priorities for 
mutual recognition agreements during the transition period may be 
dictated by FDA's ability to conduct these processes as concurrent 
functions within current activities.
    In the longer run, an operational system of mutual recognition 
agreements could pose additional costs on regulatory authorities of 
exporting countries if equivalence requires a frequency, focus or 
content of inspections not presently included in regulatory 
requirements of the exporting nation. For example, Country A may not be 
able to provide the frequency of medical device inspections desired by 
Country B without conducting inspections beyond those required for 
Country A's domestic inspection strategy. Conversely, Country B may not 
be able to provide to Country A adequate details of the quality of 
pharmaceutical source materials, because Country B does not have 
inspectional authority over pharmaceutical starting materials. To the 
extent such costs are insignificant or offset by other savings, they 
will not likely be obstacles to reaching agreement on equivalence.
    This proposal is not expected to involve any new incremental costs 
to the affected industry. Although joint inspections during the 
transition period may create the appearance of more regulatory effort, 
they should not impose additional costs on the firms inspected. FDA 
does not anticipate an increase in the total number of inspections, and 
in fact, the coverage intensity of FDA inspections in the EC would 
continue to fall during the transition period, as it has been for the 
past several years. Other activities related to equivalence 
determinations, such as the procedures for exchanging information and 
reports, focus on the interface and coordination between regulatory 
agencies and, as such, do not affect industry in a cost context.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities unless the rule is not expected to have a significant 
impact on a substantial number of small entities. As the proposed 
regulation is not expected to impose costs on the regulated industry, 
the agency certifies that the proposed rule would not have a 
significant impact on a substantial number of small entities. 
Therefore, under the Regulatory Flexibility Act, no further analysis is 
required.
    The Unfunded Mandates Act of 1995 requires that agencies prepare an 
assessment of the anticipated costs and benefits before issuing any 
final rule that may result in expenditures by State, local, and tribal 
governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one year. 
This proposed rule does not impose any mandates on State, local or 
tribal governments, or the private sector that would result in an 
annual expenditure of $100,000,000 or more. Therefore, no further 
analysis is appropriate for this requirement.

V. Paperwork Reduction Act of 1995

    This proposed rule does not contain any information collection 
provisions that would be subject to review by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520).

VI. Request for Comments

    Interested persons may, on or before May 11, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposed regulation. Comments must be received by the Dockets 
Management Branch by 4:30 p.m. Eastern Standard Time May 11, 1998. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Received comments, a 
copy of the MRA, and a summary explanation of the MRA's provisions, to 
aid in commenting, may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday. In addition, an electronic copy of the MRA 
and the summary

[[Page 17747]]

explanation is available on FDA's web site at ``http://www.fda.gov'' 
under the ``international'' heading menu item.
    The comment period in this document is shorter than the 60 days FDA 
customarily provides for proposed rules (21 CFR 10.40(b)(2)). FDA 
believes it is unnecessary to provide 60 days for comment, given the 
opportunities for public comment the agency already has provided. 
During the course of the negotiations of the MRA, FDA provided a number 
of opportunities for public discussion. For example, on May 9, 1996 (61 
FR 21194), FDA established a public docket for information concerning 
the MRA (Ref. 6). In addition, on October 18, 1996, FDA made available 
for public comment copies of a document entitled, ``FDA Proposal for an 
Agreement With the European Union Concerning the Mutual Recognition of 
Inspections to Determine Adherence to Manufacturing Practices for 
Pharmaceuticals Including Biologicals.'' FDA formally sought public 
comment on this proposal through a Federal Register notice (61 FR 
54448, October 18, 1996). To provide opportunity for public input into 
the pharmaceutical GMP discussions with the European Commission, FDA 
hosted public exchange meetings in Washington, DC, and Rockville, MD, 
on March 31, 1995 (see 60 FR 15934, March 28, 1995), and October 30, 
1996 (see 61 FR 54448, October 18, 1996). On November 8 and 9, 1996, a 
transatlantic business dialogue (TABD) meeting included an extensive 
discussion of the unresolved issues for the pharmaceutical and medical 
device annexes to the MRA (Ref. 7), and on March 14, 1997, FDA 
participated in a meeting of U.S. agencies and nongovernmental 
organizations, which included several consumer, industry, and 
environmental groups. Finally, FDA provided information and solicited 
comment on the MRA at a September 23, 1997, National Consumer Forum 
held in Washington, DC. The purpose of the forum was to facilitate 
dialogue on the MRA between FDA and consumers.
    In light of the extensive opportunities for public participation, 
FDA believes there is good cause to provide 30 days for comment on this 
proposed rule. The agency also believes it is in the public interest to 
proceed expeditiously to implement the MRA, so that it can proceed 
toward the anticipated resource efficiencies and enhancement of product 
safety, effectiveness, and quality that the MRA can provide. The 30-day 
comment period provides sufficient opportunity to receive and consider 
comments before the anticipated signing of the MRA in late spring or 
early summer.
    The agency also notes that the comment period is less than that 
required by Executive Order 12889 (58 FR 69681, December 30, 1993). 
Section 4 of Executive Order 12889 states that any agency subject to 
the Administrative Procedure Act shall provide a 75-day comment period 
for any proposed technical regulation. Because this proposed rule 
creates no new technical obligations or mandatory requirements on the 
public, FDA believes that it is not a technical regulation subject to 
Section 4 of Executive Order 12889. As a result, a 75-day comment 
period is not required for this proposed rule.

VII. References

    1. The European Community consists of the following member 
States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, 
Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, 
Sweden, and the United Kingdom. These countries have vested in the 
European Commission the authority to conduct certain international 
negotiations, on their behalf, with other countries such as the 
United States.
    2. On June 20, 1997, U.S. Trade Representative Charlene 
Barshefsky and European Commission Vice President Leon Brittan 
signed ``Agreed Minutes on the Agreement on Mutual Recognition 
between the United States of America and the European Community,'' 
which states that the MRA ``represents the text we commit to submit 
to our respective authorities with a view to completing the 
necessary procedures for approval and implementation.'' The complete 
text of the MRA is available on the Internet at FDA's web site, 
``http://www.fda.gov'', under the ``international'' menu item or on 
the European Community web site, ``http://europa.eu.int/en/comm/
dg01/mra03.htm''.
    3. Food and Drug Administration Modernization Act of 1997 
(FDAMA), section 417, Pub. L. 105-115, 111 Stat. 2296 (1997) (to be 
codified at 21 U.S.C. 360(i)(3)).
    4. Provisions in the act that govern FDA regulation of 
pharmaceuticals and medical devices include sections 501, 502, 505, 
512, 513, 520, and 522 (21 U.S.C. 351, 352, 355, 360b, 360c, 360j, 
and 360l).
    5. FDAMA section 410 (to be codified at 21 U.S.C. 383(c)(2)).
    6. Information in the docket includes summaries of minutes of 
the meetings described in this document with written comments 
received from interested parties, summaries of the various 
negotiation sessions between FDA and the European Commission and EC 
Member State representatives, and copies of draft agreements 
covering pharmaceutical GMP's and medical devices that were 
exchanged between the EC and FDA in December 1996 and January 1997.
    7. The TABD is an industry-driven initiative that aims to 
facilitate closer economic relations between the EC and the United 
States.

VIII. Comparison Table

    The following table shows the relationship of the MRA Articles and 
the sections of the Code of Federal Regulations (CFR) as proposed under 
this rule:

    Table 1.--Relationship of the MRA Articles to sections in the CFR   
------------------------------------------------------------------------
                MRA Article                          CFR Section        
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  Sectoral Annex for Pharmaceutical GMP's              Subpart A        
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Article 1.................................  26.1                        
Article 2.................................  26.2                        
Article 3.................................  26.3                        
Article 4.................................  26.4                        
Article 5.................................  26.5                        
Article 6.................................  26.6                        
Article 7.................................  26.7                        
Article 8.................................  26.8                        
Article 9.................................  26.9                        
Article 10................................  26.10                       
Article 11................................  26.11                       
Article 12................................  26.12                       
Article 13................................  26.13                       
Article 14................................  26.14                       
Article 15................................  26.15                       
Article 16................................  26.16                       
Article 17................................  26.17                       
Article 18................................  26.18                       
Article 19................................  26.19                       
Article 20................................  26.20                       
Article 21................................  26.21                       
Appendix 1................................  Appendix A                  
Appendix 2................................  Appendix B                  
Appendix 3................................  Appendix C                  
Appendix 4................................  Appendix D                  
Appendix 5................................  Appendix E                  
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                MRA Article                          CFR Section        
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     Sectoral Annex on Medical Devices                Subpart B         
------------------------------------------------------------------------
Article 1.................................  26.31                       
Article 2.................................  26.32                       
Article 3.................................  26.33                       
Article 4.................................  26.34                       
Article 5.................................  26.35                       
Article 6.................................  26.36                       
Article 7.................................  26.37                       
Article 8.................................  26.38                       
Article 9.................................  26.39                       
Article 10................................  26.40                       
Article 11................................  26.41                       
Article 12................................  26.42                       
Article 13................................  26.43                       
Article 14................................  26.44                       
Article 15................................  26.45                       
Article 16................................  26.46                       
Article 17................................  26.47                       
Article 18................................  26.48                       
Article 19................................  26.49                       
Article 20................................  26.50                       
Appendix 1................................  Appendix A                  

[[Page 17748]]

                                                                        
Appendix 2 and Tables 1-3.................  Appendix B and Tables 1-3   
Appendix 3 [Reserved].....................  Appendix C [Reserved]       
Appendix 4 [Reserved].....................  Appendix D [Reserved]       
Appendix 5 [Reserved].....................  Appendix E [Reserved]       
Appendix 6 [Reserved].....................  Appendix F [Reserved]       
------------------------------------------------------------------------


                                                                        
------------------------------------------------------------------------
                MRA Article                          CFR Section        
------------------------------------------------------------------------
            Umbrella Agreement                        Subpart C         
------------------------------------------------------------------------
Article 1.................................  26.60                       
Article 2.................................  26.61                       
Article 3.................................  26.62                       
Article 4.................................  26.63                       
Article 5.................................  26.64                       
Article 6.................................  26.65                       
Article 7.................................  26.66                       
Article 8.................................  26.67                       
Article 9.................................  26.68                       
Article 10................................  26.69                       
Article 11................................  26.70                       
Article 12................................  26.71                       
Article 13................................  26.72                       
Article 14................................  26.73                       
Article 15................................  26.74                       
Article 16................................  26.75                       
Article 17................................  26.76                       
Article 18................................  26.77                       
Article 19................................  26.78                       
Article 20................................  26.79                       
Article 21................................  26.80                       
Article 22................................  26.81                       
------------------------------------------------------------------------

List of Subjects in 21 CFR Part 26

    Animal and human drugs, Biologicals, Devices, Exports, Imports, 
Incorporation by reference, and Inspections.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I be 
amended by adding part 26 to read as follows:

PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING 
PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND 
CERTAIN MEDICAL DEVICE PREMARKET EVALUATION REPORTS PROVIDED BY 
EUROPEAN COMMUNITY MEMBER STATE REGULATORY AUTHORITIES AND EUROPEAN 
COMMUNITY CONFORMITY ASSESSMENT BODIES

Sec.
26.0 General.

Subpart A--Specific Sector Provisions for Pharmaceutical Good 
Manufacturing Practices

26.1 Definitions.
26.2 Purpose.
26.3 Scope.
26.4 Product coverage.
26.5 Length of transition period.
26.6 Equivalence assessment.
26.7 Participation in the equivalence assessment and determination.
26.8 Other transition activities.
26.9 Equivalence determination.
26.10 Regulatory authorities not listed as currently equivalent.
26.11 Start of operational period.
26.12 Nature of recognition of inspection reports.
26.13 Transmission of postapproval inspection reports.
26.14 Transmission of preapproval inspection reports.
26.15 Monitoring continued equivalence.
26.16 Suspension.
26.17 Role and composition of the Joint Sectoral Committee.
26.18 Regulatory collaboration.
26.19 Information relating to quality aspects.
26.20 Alert system.
26.21 Safeguard clause.
Appendix A of Subpart A--List of Applicable Laws, Regulations, and 
Administrative provisions.
Appendix B of Subpart A--List of Authorities.
Appendix C of Subpart A--Indicative List of Products Covered by 
Subpart A.
Appendix D of Subpart A--Criteria for Assessing Equivalence for 
Post- and Preapproval.
Appendix E of Subpart A--Elements to be Considered in Developing a 
Two-way Alert System.

Subpart B--Specific Sector Provisions for Medical Devices

26.31 Purpose.
26.32 Scope.
26.33 Product coverage.
26.34 Regulatory authorities.
26.35 Length and purpose of transition period.
26.36 Listing of CAB's.
26.37 Confidence building activities.
26.38 Other transition period activities.
26.39 Equivalence assessment.
26.40 Start of the operational period.
26.41 Exchange and endorsement of quality system evaluation reports.
26.42 Exchange and endorsement of product evaluation reports.
26.43 Transmission of quality system evaluation reports.
26.44 Transmission of product evaluation reports.
26.45 Monitoring continued equivalence.
26.46 Listing of additional CAB's.
26.47 Role and composition of the Joint Sectoral Committee.
26.48 Harmonization.
26.49 Regulatory cooperation.
26.50 Alert system and exchange of postmarket vigilance reports.
Appendix A of Subpart B--Relevant Legislation, Regulations and 
Procedures
Appendix B of Subpart B--Scope of Product Coverage
Appendix C of Subpart B [Reserved]
Appendix D of Subpart B [Reserved]
Appendix E of Subpart B [Reserved]
Appendix F of Subpart B [Reserved]

Subpart C--Framework or ``Umbrella'' Provisions

26.60 Definitions.
26.61 Purpose of this part.
26.62 General obligations.
26.63 General coverage of this part.
26.64 Transitional arrangements.
26.65 Designating authorities.
26.66 Designation and listing procedures.
26.67 Suspension of listed conformity assessment bodies.
26.68 Withdrawal of listed conformity assessment bodies.
26.69 Monitoring of conformity assessment bodies.
26.70 Conformity assessment bodies.
26.71 Exchange of information.
26.72 Sectoral contact points.
26.73 Joint Committee.
26.74 Preservation of regulatory authority.
26.75 Suspension of recognition obligations.
26.76 Confidentiality.
26.77 Fees.
26.78 Agreements with other countries.
26.79 Territorial application.
26.80 Entry into force, amendment and termination.
26.81 Final provisions.
    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 351, 
352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, 360i, 360j, 
360l, 371, 374, 381, 382, 383, 393; 42 U.S.C. 216, 241, 242l, 262, 
264, 265.

Sec. 26.0  General.

    This part substantially reflects relevant provisions of the 
proposed international agreement entitled, ``Agreement on Mutual 
Recognition Between the United States of America and the European 
Community'' (the MRA), including the ``umbrella'' text and its sectoral 
annexes on pharmaceutical good manufacturing practices (GMP's) and 
medical devices. Whereas the parties to the MRA would be the United 
States and the European Community (EC), this part is relevant only to 
the Food and Drug Administration's (FDA's) implementation of the MRA 
and the

[[Page 17749]]

sectoral annexes cited in this section. For codification purposes, 
certain provisions of the MRA have been modified for use in this part. 
This modification is done for purposes of clarity only and shall not 
affect the text of the MRA to be concluded between the United States 
and the EC, or the rights and obligations of the United States or EC 
under that agreement. References to the terms ``party'' or ``parties'' 
reflect FDA's proposed implementation of the MRA and its sectoral 
annexes. It is understood that the EC will also be a party to the MRA 
and that it will implement the MRA in accordance with its internal 
procedures. If the parties to the MRA subsequently amend or terminate 
the MRA, FDA will modify this part accordingly, using appropriate 
administrative procedures.

Subpart A--Specific Sector Provisions for Pharmaceutical Good 
Manufacturing Practices


Sec. 26.1  Definitions.

    (a) Enforcement means action taken by an authority to protect the 
public from products of suspect quality, safety, and efficacy or to 
assure that products are manufactured in compliance with appropriate 
laws, regulations, standards, and commitments made as part of the 
approval to market a product.
    (b) Equivalence of the regulatory systems means that the systems 
are sufficiently comparable to assure that the process of inspection 
and the ensuing inspection reports will provide adequate information to 
determine whether respective statutory and regulatory requirements of 
the authorities have been fulfilled. Equivalence does not require that 
the respective regulatory systems have identical procedures.
    (c) Good Manufacturing Practices (GMP's): [These GMP conceptual 
definitions are to be merged by the parties at a future date.]
    (1) GMP's mean the requirements found in the respective 
legislations, regulations, and administrative provisions for methods to 
be used in, and the facilities or controls to be used for, the 
manufacturing, processing, packing, and/or holding of a drug to assure 
that such drug meets the requirements as to safety, and has the 
identity and strength, and meets the quality and purity characteristics 
that it purports or is represented to possess.
    (2) GMP's are that part of quality assurance which ensures that 
products are consistently produced and controlled to quality standards. 
For the purpose of this subpart, GMP's include, therefore, the system 
whereby the manufacturer receives the specifications of the product 
and/or process from the marketing authorization/product authorization 
or license holder or applicant and ensures the product is made in 
compliance with its specifications (qualified person certification in 
the European Community (EC)).
     (d) Inspection means an onsite evaluation of a manufacturing 
facility to determine whether such manufacturing facility is operating 
in compliance with GMP's and/or commitments made as part of the 
approval to market a product.
     (e) Inspection Report means the written observations and GMP's 
compliance assessment completed by an authority listed in Appendix B of 
this subpart.
     (f) Regulatory System means the body of legal requirements for 
GMP's, inspections, and enforcements that ensure public health 
protection and legal authority to assure adherence to these 
requirements.


Sec. 26.2  Purpose.

    The provisions of this subpart govern the exchange between the 
parties and normal endorsement by the receiving regulatory authority of 
official good manufacturing practice (GMP) inspection reports after a 
transitional period aimed at determination of the equivalence of the 
regulatory systems of the parties, which is the cornerstone of this 
subpart.


Sec. 26.3  Scope.

    (a) The provisions of this subpart shall apply to pharmaceutical 
inspections carried out in the United States and Member States of the 
European Community (EC) before products are marketed (hereafter 
referred to as ``preapproval inspections'') as well as during their 
marketing (hereafter referred to as ``postapproval inspections'').
    (b) Appendix A of this subpart names the laws, regulations, and 
administrative provisions governing these inspections and the good 
manufacturing practice (GMP) requirements.
    (c) Appendix B of this subpart lists the authorities participating 
in activities under this subpart.
    (d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of 
subpart C of this part do not apply to this subpart.


Sec. 26.4  Product coverage.

    (a) These provisions will apply to medicinal products for human or 
animal use, intermediates and starting materials (as referred to in the 
European Community (EC)) and to drugs for human or animal use, 
biological products for human use, and active pharmaceutical 
ingredients (as referred to in the United States), only to the extent 
they are regulated by the authorities of both parties as listed in 
Appendix B of this subpart.
    (b) Human blood, human plasma, human tissues and organs, and 
veterinary immunologicals (under 9 CFR 101.2, ``veterinary 
immunologicals'' are referred to as ``veterinary biologicals'') are 
excluded from the scope of this subpart. Human plasma derivatives (such 
as immunoglobulins and albumin), investigational medicinal products/new 
drugs, human radiopharmaceuticals, and medicinal gases are also 
excluded during the transition phase, their situation will be 
reconsidered at the end of the transition period. Products regulated by 
FDA's Center for Biologics Evaluation and Research as devices are not 
covered under this subpart.
    (c) Appendix C of this subpart contains an indicative list of 
products covered by this subpart.


Sec. 26.5  Length of transition period.

    A 3-year transition period will start immediately after the 
effective date described in Sec. 26.80(a).


Sec. 26.6  Equivalence assessment.

    (a) The criteria to be used by the parties to assess equivalence 
are listed in Appendix D of this subpart. Information pertaining to the 
criteria under European Community (EC) competence will be provided by 
the EC.
    (b) The authorities of the parties will establish and communicate 
to each other their draft programs for assessing the equivalence of the 
respective regulatory systems in terms of quality assurance of the 
products and consumer protection. These programs will be carried out, 
as deemed necessary by the regulatory authorities, for post- and 
preapproval inspections and for various product classes or processes.
    (c) The equivalence assessment shall include information exchanges 
(including inspection reports), joint training, and joint inspections 
for the purpose of assessing regulatory systems and the authorities' 
capabilities. In conducting the equivalence assessment, the parties 
will ensure that efforts are made to save resources.
    (d) Equivalence assessment for authorities added to Appendix B of 
this subpart after the effective date of this part as described in 
Sec. 26.80(a) will be conducted as described in this subpart, as soon 
as practicable.

[[Page 17750]]

Sec. 26.7  Participation in the equivalence assessment and 
determination.

    The authorities listed in Appendix B of this subpart will actively 
participate in these programs to build a sufficient body of evidence 
for their equivalence determination. Both parties will exercise good 
faith efforts to complete equivalence assessment as expeditiously as 
possible to the extent the resources of the authorities allow.


Sec. 26.8  Other transition activities.

    As soon as possible, the authorities will jointly determine the 
essential information which must be present in inspection reports and 
will cooperate to develop mutually agreed inspection report format(s).


Sec. 26.9  Equivalence determination.

    (a) Equivalence is established by having in place regulatory 
systems covering the criteria referred to in Appendix D of this 
subpart, and a demonstrated pattern of consistent performance in 
accordance with these criteria. A list of authorities determined as 
equivalent shall be agreed to by the Joint Sectoral Committee at the 
end of the transition period, with reference to any limitation in terms 
of inspection type (e.g., postapproval or preapproval) or product 
classes or processes.
    (b) The parties will document insufficient evidence of equivalence, 
lack of opportunity to assess equivalence or a determination of 
nonequivalence, in sufficient detail to allow the authority being 
assessed to know how to attain equivalence.


Sec. 26.10   Regulatory authorities not listed as currently equivalent.

    Authorities not currently listed as equivalent, or not equivalent 
for certain types of inspections, product classes or processes may 
apply for reconsideration of their status once the necessary corrective 
measures have been taken or additional experience is gained.


Sec. 26.11   Start of operational period.

    (a) The operational period shall start at the end of the transition 
period and its provisions apply to inspection reports generated by 
authorities listed as equivalent for the inspections performed in their 
territory.
    (b) In addition, when an authority is not listed as equivalent 
based on adequate experience gained during the transition period, FDA 
will accept for normal endorsement (as provided in Sec. 26.12) 
inspection reports generated as a result of inspections conducted 
jointly by that authority on its territory and another authority listed 
as equivalent, provided that the authority of the Member State in which 
the inspection is performed can guarantee enforcement of the findings 
of the inspection report and require that corrective measures be taken 
when necessary. FDA has the option to participate in these inspections, 
and based on experience gained during the transition period, the 
parties will agree on procedures for exercising this option.
    (c) In the European Community (EC), the qualified person will be 
relieved of responsibility for carrying the controls laid down in 
Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see Appendix 
A of this subpart) provided that these controls have been carried out 
in the United States and that each batch/lot is accompanied by a batch 
certificate (in accordance with the World Health Organization 
Certification Scheme on the Quality of Medicinal Products) issued by 
the manufacturer certifying that the product complies with requirements 
of the marketing authorization and signed by the person responsible for 
releasing the batch/lot.


Sec. 26.12  Nature of recognition of inspection reports.

    (a) Inspection reports (containing information as established under 
Sec. 26.8), including a good manufacturing practice (GMP) compliance 
assessment, prepared by authorities listed as equivalent, will be 
provided to the authority of the importing party. Based on the 
determination of equivalence in light of the experience gained, these 
inspection reports will normally be endorsed by the authority of the 
importing party, except under specific and delineated circumstances. 
Examples of such circumstances include indications of material 
inconsistencies or inadequacies in an inspection report, quality 
defects identified in the postmarket surveillance or other specific 
evidence of serious concern in relation to product quality or consumer 
safety. In such cases, the authority of the importing party may request 
clarification from the authority of the exporting party which may lead 
to a request for reinspection. The authorities will endeavor to respond 
to requests for clarification in a timely manner.
    (b) Where divergence is not clarified in this process, an authority 
of the importing country may carry out an inspection of the production 
facility.


Sec. 26.13  Transmission of postapproval inspection reports.

    Postapproval good manufacturing practice (GMP) inspection reports 
concerning products covered by this subpart will be transmitted to the 
authority of the importing country within 60 calendar days of the 
request. Should a new inspection be needed, the inspection report will 
be transmitted within 90 calendar days of the request.


Sec. 26.14  Transmission of preapproval inspection reports.

    (a) A preliminary notification that an inspection may have to take 
place will be made as soon as possible.
    (b) Within 15 calendar days, the relevant authority will 
acknowledge receipt of the request and confirm its ability to carry out 
the inspection. In the European Community (EC), requests will be sent 
directly to the relevant authority, with a copy to the European Agency 
for the Evaluation of Medicinal Products (EMEA). If the authority 
receiving the request cannot carry out the inspection as requested, the 
requesting authority shall have the right to conduct the inspection.
    (c) Reports of preapproval inspections will be sent within 45 
calendar days of the request that transmitted the appropriate 
information and detailed the precise issues to be addressed during the 
inspection. A shorter time may be necessary in exceptional cases and 
these will be described in the request.


Sec. 26.15   Monitoring continued equivalence.

    Monitoring activities for the purpose of maintaining equivalence 
shall include review of the exchange of inspection reports and their 
quality and timeliness; performance of a limited number of joint 
inspections; and the conduct of common training sessions.


Sec. 26.16   Suspension.

    (a) Each party has the right to contest the equivalence of a 
regulatory authority. This right will be exercised in an objective and 
reasoned manner in writing to the other party.
    (b) The issue shall be discussed in the Joint Sectoral Committee 
promptly upon such notification. Where the Joint Sectoral Committee 
determines that verification of equivalence is required, it may be 
carried out jointly by the parties in a timely manner, under Sec. 26.6.
    (c) Efforts will be made by the Joint Sectoral Committee to reach 
unanimous consent on the appropriate action. If agreement to suspend is 
reached in the Joint Sectoral Committee, an authority may be suspended 
immediately thereafter. If no agreement is reached in the Joint 
Sectoral Committee, the matter is referred to the Joint Committee as 
described in Sec. 26.73. If no unanimous consent is reached within 30 
days after such notification, the contested authority will be 
suspended.
    (d) Upon the suspension of authority previously listed as 
equivalent, a party

[[Page 17751]]

is no longer obligated to normally endorse the inspection reports of 
the suspended authority. A party shall continue to normally endorse the 
inspection reports of that authority prior to suspension, unless the 
authority of the receiving party decides otherwise based on health or 
safety considerations. The suspension will remain in effect until 
unanimous consent has been reached by the parties on the future status 
of that authority.


Sec. 26.17  Role and composition of the Joint Sectoral Committee.

    (a) A Joint Sectoral Committee is set up to monitor the activities 
under both the transitional and operational phases of this subpart.
    (b) The Joint Sectoral Committee will be cochaired by a 
representative of FDA for the United States and a representative of the 
European Community (EC) who each will have one vote. Decisions will be 
taken by unanimous consent.
    (c) The Joint Sectoral Committee's functions will include:
    (1) Making a joint assessment, which must be agreed by both 
parties, of the equivalence of the respective authorities;
    (2) Developing and maintaining the list of equivalent authorities, 
including any limitation in terms of inspecting type or products, and 
communicating the list to all authorities and the Joint Committee;
    (3) Providing a forum to discuss issues relating to this subpart, 
including concerns that an authority may be no longer equivalent and 
opportunity to review product coverage; and
    (4) Consideration of the issue of suspension.
    (d) The Joint Sectoral Committee shall meet at the request of 
either party and, unless the cochairs otherwise agree, at least once 
each year. The Joint Committee will be kept informed of the agenda and 
conclusions of meetings of the Joint Sectoral Committee.


Sec. 26.18   Regulatory collaboration.

    (a) The parties and authorities shall inform and consult one 
another, as permitted by law, on proposals to introduce new controls or 
to change existing technical regulations or inspection procedures and 
to provide the opportunity to comment on such proposals.
    (b) The parties shall notify each other in writing of any changes 
to Appendix B of this subpart.


Sec. 26.19   Information relating to quality aspects.

    The authorities will establish an appropriate means of exchanging 
information on any confirmed problem reports, corrective actions, 
recalls, rejected import consignments and other regulatory and 
enforcement problems for products subject to this subpart.


Sec. 26.20  Alert system.

    (a) The details of an alert system will be developed during the 
transitional period. The system will be maintained in place at all 
times. Elements to be considered in developing such a system are 
described in Appendix E of this subpart.
    (b) Contact points will be agreed between both parties to permit 
authorities to be made aware with the appropriate speed in case of 
quality defect, recalls, counterfeiting, and other problems concerning 
quality, which could necessitate additional controls or suspension of 
the distribution of the product.


Sec. 26.21  Safeguard clause.

    Each party recognizes that the importing country has a right to 
fulfill its legal responsibilities by taking actions necessary to 
ensure the protection of human and animal health at the level of 
protection it deems appropriate. This includes the suspension of the 
distribution, product detention at the border of the importing country, 
withdrawal of the batches and any request for additional information or 
inspection as provided in Sec. 26.12.

Appendix A of Subpart A--List of Applicable Laws, Regulations, and 
Administrative Provisions

1. For the European Community:

    [Copies of EC documents may be obtained from the European 
Document Research, 1100 17th St. NW., suite 301, Washington, DC 
20036. EC documents may be viewed on the European Commission 
Pharmaceuticals Units web site at ``http://dg3.eudra.org.'']
Council Directive 65/65/EEC of 26 January 1965 on the approximation 
of provisions laid down by law, regulation, or administrative action 
relating to proprietary medicinal products as extended, widened, and 
amended.
Council Directive 75/319/EEC of 20 May 1975 on the approximation of 
provisions laid down by law, regulation or administrative action 
relating to proprietary medicinal products as extended, widened and 
amended.
Council Directive 81/851/EEC of 6 November 1981 on the approximation 
of the laws of the Member States relating to veterinary medicinal 
products as widened and amended.
Commission Directive 91/356/EEC of 13 June 1991 laying down the 
principles and guidelines of good manufacturing practice for 
medicinal products for human use.
Commission Directive 91/412/EEC of 23 July 1991 laying down the 
principles and guidelines of good manufacturing practice for 
veterinary medicinal products.
Council Regulation No (EEC) 2309/93 of 23 July 1993 laying down 
Community procedures for the authorization and supervision of 
medicinal products for human and veterinary use and establishing a 
European Agency for the Evaluation of Medicinal Products.
Council Directive 92/25/EEC of 31 March 1992 on the wholesale 
distribution of medicinal products for human use & Guide to Good 
Distribution Practice.
Current version of the Guide to Good Manufacturing Practice, Rules 
Governing Medicinal Products in the European Community, Volume IV.

2. For the United States :

    [Copies of FDA documents may be obtained from the Government 
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA 
documents, except the FDA Compliance Program Guidance Manual, may be 
viewed on FDA's Internet web site at ``http://www.FDA.gov''.]
Relevant sections of the United States Federal Food, Drug, and 
Cosmetic Act and the United States Public Health Service Act.
Relevant sections of Title 21, United States Code of Federal 
Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and 
Parts 600-799.
Relevant sections of the FDA Investigations Operations Manual, the 
FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance 
Manual, the FDA Compliance Program Guidance Manual, and other FDA 
guidances.

Appendix B of Subpart A--List of Authorities

1. For the United States:

In the United States, the regulatory authority is the Food and Drug 
Administration.

2. For the European Community:

In the European Community, the regulatory authorities are the 
following :
 Austria: Bundesministerium Fur Arbeit, Gesundheit, und Soziales, 
Wien.
Belgium: Ministerie van Sociale Zakem, Volksgezondheid en Leefmilieu 
/Ministere des Affaires Sociales, Sante Publique et Environment/ 
Algemeine Farmaceutische Inspectie, Inspection Generale de la 
Pharmacie, Bruxelles, Brussel.
Denmark: Laegemiddelstryelsen, (Danish Medicines Agency), Bronshoj.
Finland: Laakelaittos/Lakemedelsverket (National Agency for 
Medicines), Helsinki.
France: Agence du Medicament, Direction de l'inspection et des 
etablissements, Saint Denis. (Human). Agence Nationale du Medicament 
Veterinaire, Fougeres (Veterinary).
Germany: Bundesgesundheitsministerium, Bonn. Paul-Ehrlich Institut, 
Langen (biologicals only). Zustandige Behorden der 16 Bundeslander: 
Bayern, Berlin Brandenberg, Bremen, Hamburg, Hessen, Niedersachsen, 
Nordrhein-Westfalen, Rheinland-Pfalz, Mecklenberg-Vorpommern, 
Saarland, Sachsen, Sachsenanhalt, Schleswog-Holstein, Thuringen.
Greece: Ministry of Health and Welfare, National Drug Organisation 
(E.O.F.), Athens.
Ireland: Irish Medicines Board, Dublin.

[[Page 17752]]

Italy: Ministero della Sanita, Dipartimento Farmaci e 
Farmacovigilanza, Roma. (Human). Ministero della Sanita, 
Dipartimento alimenti e nutrizione e sanita pubblica veterinaria - 
Div. IX, Roma (Veterinary).
Luxembourg: Direction de la Sante, Division de la Pharmacie et des 
Medicaments, Luxembourg.
The Netherlands: Staatstoezicht op de Volksgezondheid, Inspectie 
voor de Gezondheidszorg, Rijswijk.
Portugal: Instituto da Farmacia e do Medicamento (INFARMED), Lisboa.
Spain: Ministerio Sanidad y Consumo, Subdireccion. General de 
Control Farmaceutico, Madrid. (Human) Ministerio de Agricultura 
Pesca y Alimentacion, Madrid, (Veterinary).
Sweden: Lakemedelsverket (Medical Products Agency), Uppsala.
United Kingdom: Medicines Control Agency, London. Veterinary 
Medicines Directorate, Addlestone.
European Union: European Commission, Brussels. European Agency for 
the Evaluation of Medicinal Products (EMEA), London.

Appendix C of Subpart A--Indicative List of Products Covered by Subpart 
A

Recognizing that precise definition of medicinal products and drugs 
are to be found in the legislations referred to above, an indicative 
list of products covered by this arrangement is given below:
    - human medicinal products including prescription and 
nonprescription drugs;
    - human biologicals including vaccines, and immunologicals;
    - veterinary pharmaceuticals, including prescription and 
nonprescription drugs, with the exclusion of veterinary 
immunologicals (Under 9 CFR 101.2 ``veterinary immunologicals'' are 
referred to as ``veterinary biologicals.'');
    - premixes for the preparation of veterinary medicated feeds 
(EC), Type A medicated articles for the preparation of veterinary 
medicated feeds (United States);
    - intermediate products and active pharmaceutical ingredients or 
bulk pharmaceuticals (United States)/starting materials (EC).

Appendix D of Subpart A--Criteria for Assessing Equivalence for Post- 
and Preapproval

I. Legal/Regulatory authority and structures and procedures providing 
for post- and preapproval:

A. Appropriate statutory mandate and jurisdiction.
B. Ability to issue and update binding requirements on GMP's and 
guidance documents.
C. Authority to make inspections, review and copy documents, and to 
take samples and collect other evidence.
D. Ability to enforce requirements and to remove products found in 
violation of such requirements from the market.
E. Substantive current good manufacturing requirements.
F. Accountability of the regulatory authority.
G. Inventory of current products and manufacturers.
H. System for maintaining or accessing inspection reports, samples 
and other analytical data, and other firm/product information 
relating to matters covered by subpart A of this part.

II. Mechanisms in place to assure appropriate professional standards 
and avoidance of conflicts of interest.

III. Administration of the regulatory authority:

A. Standards of education/qualification and training.
B. Effective quality assurance systems measures to ensure adequate 
job performance.
C. Appropriate staffing and resources to enforce laws and 
regulations.

IV. Conduct of inspections:

A. Adequate preinspection preparation, including appropriate 
expertise of investigator/team, review of firm/product and 
databases, and availability of appropriate inspection equipment.
B. Adequate conduct of inspection, including statutory access to 
facilities, effective response to refusals, depth and competence of 
evaluation of operations, systems, and documentation; collection of 
evidence; appropriate duration of inspection and completeness of 
written report of observations to firm management.
C. Adequate postinspection activities, including completeness of 
inspectors' report, inspection report review where appropriate, and 
conduct of followup inspections and other activities where 
appropriate, assurance of preservation and retrieval of records.

V. Execution of regulatory enforcement actions to achieve corrections, 
designed to prevent future violations, and to remove products found in 
violation of requirements from the market.

VI. Effective use of surveillance systems:

A. Sampling and analysis.
B. Recall monitoring.
C. Product defect reporting system.
D. Routine surveillance inspections.
E. Verification of approved manufacturing process changes to 
marketing authorizations/approved applications.

VII. Additional specific criteria for preapproval inspections:

A. Satisfactory demonstration through a jointly developed and 
administered training program and joint inspections to assess the 
regulatory authorities' capabilities.
B. Preinspection preparation includes the review of appropriate 
records, including site plans and drug master file or similar 
documentation to enable adequate inspections.
C. Ability to verify chemistry, manufacturing, and control data 
supporting an application is authentic and complete.
D. Ability to assess and evaluate research and development data as 
scientifically sound, especially transfer technology of pilot, scale 
up and full scale production batches.
E. Ability to verify conformity of the onsite processes and 
procedures with those described in the application.
F. Review and evaluate equipment installation, operational and 
performance qualification data, and evaluate test method validation.

Appendix E of Subpart A--Elements to be Considered in Developing a Two-
way Alert System

1. Documentation

- Definition of a crisis/emergency and under what circumstances an 
alert is required
- Standard Operating Procedures (SOP's)
- Mechanism of health hazards evaluation and classification
- Language of communication and transmission of information

2. Crisis Management System

- Crisis analysis and communication mechanisms
- Establishment of contact points
- Reporting mechanisms

3. Enforcement Procedures

- Followup mechanisms
- Corrective action procedures

4. Quality Assurance System

- Pharmacovigilance programme
- Surveillance/monitoring of implementation of corrective action

5. Contact Points

For the purpose of subpart A of this part, the contact points for 
the alert system will be:

A. For the European Community:

the Executive Director of the European Agency for the Evaluation of 
Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London 
E14 4HB, England. Telephone 44-171-418 8400, Fax 418 8416.

B. For the United States :

Division of Emergency and Investigational Operations (DEIO), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Telephone 301-443-1240, Fax 301-443-3757.

 Subpart B--Specific Sector Provisions for Medical Devices


Sec. 26.31  Purpose.

    (a) The purpose of this subpart is to specify the conditions under 
which a party will accept the results of quality system-related 
evaluations and inspections and premarket evaluations of the other 
party with regard to medical devices as conducted by listed conformity 
assessment bodies (CAB's) and to provide for other related cooperative 
activities.
    (b) This subpart is intended to evolve as programs and policies of 
the parties evolve. The parties will review this subpart periodically, 
in order to assess progress and identify potential enhancements to this 
subpart as FDA and European Community (EC) policies evolve over time.


Sec. 26.32  Scope.

    (a) The provisions of this subpart shall apply to the exchange and, 
where appropriate, endorsement of the following types of reports from 
conformity assessment bodies (CAB's) assessed to be equivalent:

[[Page 17753]]

    (1) Under the U.S. system, surveillance/postmarket and initial/
preapproval inspection reports;
    (2) Under the U.S. system, premarket (510(k)) product evaluation 
reports;
    (3) Under the European Community (EC) system, quality system 
evaluation reports; and
    (4) Under the EC system, EC type examination and verification 
reports.
    (b) Appendix A of this subpart names the legislation, regulations, 
and related procedures under which:
    (1) Products are regulated as medical devices by each party;
    (2) CAB's are designated and confirmed; and
    (3) These reports are prepared.
    (c) For purposes of this subpart, equivalence means that: CAB's in 
the EC are capable of conducting product and quality systems 
evaluations against U.S. regulatory requirements in a manner equivalent 
to those conducted by FDA; and CAB's in the United States are capable 
of conducting product and quality systems evaluations against EC 
regulatory requirements in a manner equivalent to those conducted by EC 
CAB's.


Sec. 26.33  Product coverage.

    (a) There are three components to this subpart each covering a 
discrete range of products:
    (1) Quality System Evaluations. U.S.-type surveillance/postmarket 
and initial/preapproval inspection reports and European Community (EC)-
type quality system evaluation reports will be exchanged with regard to 
all products regulated under both U.S. and EC law as medical devices.
    (2) Product Evaluation. U.S.-type premarket (510(k)) product 
evaluation reports and EC-type-testing reports will be exchanged only 
with regard to those products classified under the U.S. system as Class 
I/Class II-Tier 2 medical devices which are listed in Appendix B of 
this subpart.
    (3) Postmarket Vigilance Reports. Postmarket vigilance reports will 
be exchanged with regard to all products regulated under both U.S. and 
EC law as medical devices.
    (b) Additional products and procedures may be made subject to this 
subpart by agreement of the parties.


Sec. 26.34  Regulatory authorities.

    The regulatory authorities shall have the responsibility of 
implementing the provisions of this subpart, including the designation 
and monitoring of conformity assessment bodies (CAB's). Regulatory 
authorities will be specified in Appendix C of this subpart.. Each 
party will promptly notify the other party in writing of any change in 
the regulatory authority for a country.


Sec. 26.35  Length and purpose of transition period.

    There will be a 3-year transition period immediately following the 
date described in Sec. 26.80(a). During the transition period, the 
parties will engage in confidence-building activities for the purpose 
of obtaining sufficient evidence to make determinations concerning the 
equivalence of conformity assessment bodies (CAB's) of the other party 
with respect to the ability to perform quality system and product 
evaluations or other reviews resulting in reports to be exchanged under 
this subpart.


Sec. 26.36  Listing of CAB's.

    Each party shall designate conformity assessment bodies (CAB's) to 
participate in confidence-building activities by transmitting to the 
other party a list of CAB's which meet the criteria for technical 
competence and independence, as identified in Appendix A of this 
subpart. The list shall be accompanied by supporting evidence. 
Designated CAB's will be listed in Appendix D of this subpart for 
participation in the confidence building activities once confirmed by 
the importing party. Nonconfirmation would have to be justified based 
on documented evidence.


Sec. 26.37  Confidence building activities.

    (a) At the beginning of the transitional period, the Joint Sectoral 
Group will establish a joint confidence building program calculated to 
provide sufficient evidence of the capabilities of the designated 
conformity assessment bodies (CAB's) to perform quality system or 
product evaluations to the specifications of the parties.
    (b) The joint confidence building program should include the 
following actions and activities:
    (1) Seminars designed to inform the parties and CAB's about each 
party's regulatory system, procedures, and requirements;
    (2) Workshops designed to provide the parties with information 
regarding requirements and procedures for the designation and 
surveillance of CAB's;
    (3) Exchange of information about reports prepared during the 
transition period;
    (4) Joint training exercises; and
    (5) Observed inspections.
    (c) During the transition period, any significant problem that is 
identified with a CAB may be the subject of cooperative activities, as 
resources allow and as agreed to by the regulatory authorities, aimed 
at resolving the problem.
    (d) Both parties will exercise good faith efforts to complete the 
confidence building activities as expeditiously as possible to the 
extent that the resources of the parties allow.
    (e) Both the parties will each prepare annual progress reports 
which will describe the confidence building activities undertaken 
during each year of the transition period. The form and content of the 
reports will be determined by the parties through the Joint Sectoral 
Committee.


Sec. 26.38  Other transition period activities.

    (a) During the transition period, the parties will jointly 
determine the necessary information which must be present in quality 
system and product evaluation reports.
    (b) The parties will jointly develop a notification and alert 
system to be used in case of defects, recalls, and other problems 
concerning product quality that could necessitate additional actions 
(e.g., inspections by the parties of the importing country) or 
suspension of the distribution of the product.


Sec. 26.39  Equivalence assessment.

    (a) In the final 6 months of the transition period, the parties 
shall proceed to a joint assessment of the equivalence of the 
conformity assessment bodies (CAB's) that participated in the 
confidence building activities. CAB's will be determined to be 
equivalent provided they have demonstrated proficiency through the 
submission of a sufficient number of adequate reports. CAB's may be 
determined to be equivalent with regard to the ability to perform any 
type of quality system or product evaluation covered by this subpart 
and with regard to any type of product covered by this subpart. The 
parties shall develop a list contained in Appendix E of this subpart of 
CAB's determined to be equivalent which shall contain a full 
explanation of the scope of the equivalency determination, including 
any appropriate limitations, with regard to performing any type of 
quality system or product evaluation.
    (b) The parties shall allow CAB's not listed for participation in 
this subpart, or listed for participation only as to certain types of 
evaluations, to apply for participation in this subpart once the 
necessary measures have been taken or sufficient experience has been 
gained, in accordance with Sec. 26.46.
    (c) Decisions concerning the equivalence of CAB's must be agreed to 
by both parties.

[[Page 17754]]

Sec. 26.40  Start of the operational period.

    (a) The operational period will start at the end of the transition 
period after the parties have developed the list of conformity 
assessment bodies (CAB's) found to be equivalent. The provisions of 
Secs. 26.40, 26.41, 26.42, 26.43, 26.44, 26.45, and 26.46 will apply 
only with regard to listed CAB's and only to the extent of any 
specifications and limitations contained on the list with regard to a 
CAB.
    (b) The operational period will apply to quality system evaluation 
reports and product evaluation reports generated by CAB's listed in 
accordance with this subpart for the evaluations performed in the 
respective territories of the parties, except if the parties agree 
otherwise.


Sec. 26.41  Exchange and endorsement of quality system evaluation 
reports.

    (a) Listed European Community (EC) conformity assessment bodies 
(CAB's) will provide FDA with reports of quality system evaluations, as 
follows:
    (1) For preapproval quality system evaluations, EC CAB's will 
provide full reports; and
    (2) For surveillance quality system evaluations, EC CAB's will 
provide abbreviated reports.
    (b) Listed U.S. CAB's will provide to the EC Notified Body of the 
manufacturer's choice:
    (1) Full reports of initial quality system evaluations;
    (2) Abbreviated reports of quality systems surveillance audits.
    (c) If the abbreviated reports do not provide sufficient 
information, the importing party may request additional clarification 
from the CAB.
    (d) Based on the determination of equivalence in light of the 
experience gained, the quality system evaluation reports prepared by 
the CAB's listed as equivalent will normally be endorsed by the 
importing party, except under specific and delineated circumstances. 
Examples of such circumstances include indications of material 
inconsistencies or inadequacies in a report, quality defects identified 
in postmarket surveillance or other specific evidence of serious 
concern in relation to product quality or consumer safety. In such 
cases, the importing party may request clarification from the exporting 
party which may lead to a request for reinspection. The parties will 
endeavor to respond to requests for clarification in a timely manner. 
Where divergence is not clarified in this process, the importing party 
may carry out the quality system evaluation.


Sec. 26.42  Exchange and endorsement of product evaluation reports.

    (a) European Community (EC) conformity assessment bodies (CAB's) 
listed for this purpose will, subject to the specifications and 
limitations on the list, provide to FDA 510(k) premarket notification 
assessment reports prepared to U.S. medical device requirements.
    (b) U.S. CAB's will, subject to the specifications and limitations 
on the list, provide to the EC Notified Body of the manufacturer's 
choice, type examination, and verification reports prepared to EC 
medical device requirements.
    (c) Based on the determination of equivalence in light of the 
experience gained, the product evaluation reports prepared by the CAB's 
listed as equivalent will normally be endorsed by the importing party, 
except under specific and delineated circumstances. Examples of such 
circumstances include indications of material inconsistencies, 
inadequacies, or incompleteness in a product evaluation report, or 
other specific evidence of serious concern in relation to product 
safety, performance, or quality. In such cases, the importing party may 
request clarification from the exporting party which may lead to a 
request for a reevaluation. The parties will endeavor to respond to 
requests for clarification in a timely manner. Endorsement remains the 
responsibility of the importing party.


Sec. 26.43  Transmission of quality system evaluation reports.

    Quality system evaluation reports covered by Sec. 26.41 concerning 
products covered by this subpart shall be transmitted to the importing 
party within 60 calendar days of a request by the importing party. 
Should a new inspection be requested, the time period shall be extended 
by an additional 30 calendar days. A party may request a new 
inspection, for cause, identified to the other party. If the exporting 
party cannot perform an inspection within a specified period of time, 
the importing party may perform an inspection on its own.


Sec. 26.44  Transmission of product evaluation reports.

    Transmission of product evaluation reports will take place 
according to the importing party's specified procedures.


Sec. 26.45  Monitoring continued equivalence.

    Monitoring activities will be carried out in accordance with 
Sec. 26.69.


Sec. 26.46  Listing of additional CAB's.

    (a) During the operational phase, additional conformity assessment 
bodies (CAB's) will be considered for equivalence using the procedures 
and criteria described in Secs. 26.36, 26.37, and 26.39, taking into 
account the level of confidence gained in the overall regulatory system 
of the other party.
    (b) Once a designating authority considers that such CAB's, having 
undergone the procedures of Secs. 26.36, 26.37, and 26.39, may be 
determined to be equivalent, it will then designate those bodies on an 
annual basis. Such procedures satisfy the procedures of Sec. 26.66(a) 
and (b).
    (c) Following such annual designations, the procedures for 
confirmation of CAB's under Sec. 26.66(c) and (d) shall apply.


Sec. 26.47  Role and composition of the Joint Sectoral Committee.

    (a) The Joint Sectoral Committee for this subpart is set up to 
monitor the activities under both the transitional and operational 
phases of this subpart.
    (b) The Joint Sectoral Committee will be cochaired by a 
representative of the Food and Drug Administration (FDA) for the United 
States and a representative of the European Community (EC) who will 
each have one vote. Decisions will be taken by unanimous consent.
    (c) The Joint Sectoral Committee's functions will include:
    (1) Making a joint assessment of the equivalence of conformity 
assessment bodies (CAB's);
    (2) Developing and maintaining the list of equivalent CAB's, 
including any limitation in terms of their scope of activities and 
communicating the list to all authorities and the Joint Committee 
described in subpart C of this part;
    (3) Providing a forum to discuss issues relating to this subpart, 
including concerns that a CAB may no longer be equivalent and 
opportunity to review product coverage; and
    (4) Consideration of the issue of suspension.


Sec. 26.48   Harmonization.

    During both the transitional and operational phases of this 
subpart, both parties intend to continue to participate in the 
activities of the Global Harmonization Task Force and utilize the 
results of those activities to the extent possible. Such participation 
involves developing and reviewing documents developed by the Global 
Harmonization Task Force and jointly determining whether they are 
applicable to the implementation of this subpart.


Sec. 26.49  Regulatory cooperation.

    (a) The parties and authorities shall inform and consult with one 
another, as permitted by law, of proposals to

[[Page 17755]]

introduce new controls or to change existing technical regulations or 
inspection procedures and to provide the opportunity to comment on such 
proposals.
    (b) The parties shall notify each other in writing of any changes 
to Appendix A of this subpart.


Sec. 26.50  Alert system and exchange of postmarket vigilance reports.

    (a) An alert system will be set up during the transition period and 
maintained thereafter by which the parties will notify each other when 
there is an immediate danger to public health. Elements of such a 
system will be described in an Appendix F of this subpart. As part of 
that system, each party shall notify the other party of any confirmed 
problem reports, corrective actions, or recalls. These reports are 
regarded as part of ongoing investigations.
    (b) Contact points will be agreed between both parties to permit 
authorities to be made aware with the appropriate speed in case of 
quality defect, batch recalls, counterfeiting and other problems 
concerning quality, which could necessitate additional controls or 
suspension of the distribution of the product.

Appendix A of Subpart B--Relevant Legislation, Regulations and 
Procedures

1. For the European Community (EC) the following legislation applies to 
Sec. 26.42(a) of this subpart:

    [Copies of EC documents may be obtained from the European 
Document Research, 1100 17th St. NW., suite 301, Washington, DC 
20036.]
a. Council Directive 90/385/EEC of 20 June 1990 on active 
implantable medical devices
    OJ No. L 189, 20.7. 1990, p. 17. Conformity assessment 
procedures.
    Annex 2 (with the exception of section 4)
    Annex 4
    Annex 5
b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ 
No. L 169,12.7.1993, p.1. Conformity assessment procedures.
    Annex 2 (with the exception of section 4)
    Annex 3
    Annex 4
    Annex 5
    Annex 6

2. For the United States, the following legislation applies to 
Sec. 26.32(a):

    [Copies of FDA documents may be obtained from the Government 
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents 
may be viewed on FDA's Internet web site at ``http://www.fda.gov''.]
a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq.
b. The Public Health Service Act, 42 U.S.C. 201 et seq.
c. Regulations of the United States Food and Drug Administration 
found at 21 CFR, in particular, Parts 800 to 1299.
d. Medical Devices; Third Party Review of Selected Premarket 
Notifications; Pilot Program, 61 FR 14789-14796 (April 3, 1996).

Appendix B of Subpart B--Scope of Product Coverage

1. Initial Coverage of the Transition Period

Upon entry into force of this subpart as described in Sec. 26.80 (it 
is understood that the date of entry into force will not occur prior 
to June 1, 1998, unless the parties decide otherwise), products 
qualifying for the transitional arrangements under this subpart 
include:
    a. All Class I products requiring premarket evaluations in the 
United States--see Table 1.
    b. Those Class II products listed in Table 2.

2. During the Transition Period

The parties will jointly identify additional product groups, 
including their related accessories, in line with their respective 
priorities as follows:
    a. Those for which review may be based primarily on written 
guidance which the parties will use their best efforts to prepare 
expeditiously; and
    b. Those for which review may be based primarily on 
international standards, in order for the parties to gain the 
requisite experience.
The corresponding additional product lists will be phased in on an 
annual basis. The parties may consult with industry and other 
interested parties in determining which products will be added.

3. Commencement of the Operational Period

    a. At the commencement of the operational period, product 
coverage shall extend to all Class I/II products covered during the 
transition period.
    b. FDA will expand the program to categories of Class II devices 
as is consistent with the results of the pilot, and with FDA's 
ability to write guidance documents if the device pilot for the 
third party review of medical devices is successful. The MRA will 
cover to the maximum extent feasible all Class II devices listed in 
Table 3 for which FDA-accredited third party review is available in 
the United States.

4. Unless explicitly included by joint decision of the parties, this 
part does not cover any U.S. Class II-tier 3 or any Class III product 
under either system.

    [FDA is codifying the lists of medical devices contained in the 
following tables as they appear in the medical device annex of the 
``Agreement on Mutual Recognition Between the United States of 
America and the European Community.'' As a result of the Food and 
Drug Administration Modernization Act of 1997, however, the medical 
devices included in these tables will change.]

Table 1.--Class I Products Requiring Premarket Evaluations in the United
States, Included in Scope of Product Coverage at Beginning of Transition
                                Period\1\                               
------------------------------------------------------------------------
          21 CFR Section No.                    Regulation Name         
------------------------------------------------------------------------
                                           Product Code--Device Name    
------------------------------------------------------------------------
Anesthesiology Panel (21 CFR Part                                       
 868)                                                                   
    868.1910                           Esophageal Stethoscope           
                                       BZW--Stethoscope, Esophageal     
    868.5620                           Breathing Mouthpiece             
                                       BYP--Mouthpiece, Breathing       
    868.5640                           Medicinal Nonventilatory         
                                        Nebulizer (Atomizer)            
                                       CCQ--Nebulizer, Medicinal,       
                                        Nonventilatory (Atomizer)       
    868.5675                           Rebreathing Device               
                                       BYW--Device, Rebreathing         
    868.5700                           Nonpowered Oxygen Tent           
                                       FOG--Hood, Oxygen, Infant        
                                       BYL--Tent, Oxygen                
    868.6810                           Tracheobronchial Suction Catheter
                                       BSY--Catheters, Suction,         
                                        Tracheobronchial                

[[Page 17756]]

                                                                        
Cardiovascular Panel                                                    
    (None)                                                              
Dental Panel (21 CFR Part 872)                                          
    872.3400                           Karaya and Sodium Borate With or 
                                        Without Acacia Denture Adhesive 
                                       KOM--Adhesive, Denture, Acacia   
                                        and Karaya With Sodium Borate   
    872.3700                           Dental Mercury (U.S.P.)          
                                       ELY--Mercury                     
    872.4200                           Dental Handpiece and Accessories 
                                       EBW--Controller, Food, Handpiece 
                                        and Cord                        
                                       EFB--Handpiece, Air-Powered,     
                                        Dental                          
                                       EFA--Handpiece, Belt and/or Gear 
                                        Driven, Dental                  
                                       EGS--Handpiece, Contra- and Right-
                                        Angle Attachment, Dental        
                                       EKX--Handpiece, Direct Drive, AC-
                                        Powered                         
                                       EKY--Handpiece, Water-Powered    
    872.6640                           Dental Operative Unit and        
                                        Accessories                     
                                       EIA--Unit, Operative Dental      
Ear, Nose, and Throat Panel (21 CFR                                     
 Part 874)                                                              
    874.1070                           Short Increment Sensitivity Index
                                        (SISI) Adapter                  
                                       ETR--Adapter, Short Increment    
                                        Sensitivity Index (SISI)        
    874.1500                           Gustometer                       
                                       ETM--Gustometer                  
    874.1800                           Air or Water Caloric Stimulator  
                                       KHH--Stimulator, Caloric-Air     
                                       ETP--Stimulator, Caloric-Water   
    874.1925                           Toynbee Diagnostic Tube          
                                       ETK--Tube, Toynbee Diagnostic    
    874.3300                           Hearing Aid                      
                                       LRB--Face Plate Hearing-Aid      
                                       ESD--Hearing-aid, Air-Conduction 
    874.4100                           Epistaxis Balloon                
                                       EMX--Balloon, Epistaxis          
    874.5300                           ENT Examination and Treatment    
                                        Unit                            
                                       ETF--Unit, Examining/Treatment,  
                                        ENT                             
    874.5550                           Powered Nasal Irrigator          
                                       KMA--Irrigator, Powered Nasal    
    874.5840                           Antistammering Device            
                                       KTH--Device, Anti-Stammering     
Gastroenterology--Urology Panel (21                                     
 CFR Part 876)                                                          
    876.5160                           Urological Clamp for Males       
                                       FHA--Clamp, Penile               
    876.5210                           Enema Kit                        
                                       FCE--Kit, Enema, (for Cleaning   
                                        Purpose)                        
    876.5250                           Urine Collector and Accessories  
                                       FAQ--Bag, Urine Collection, Leg, 
                                        for External Use                
General Hospital Panel (21 CFR Part                                     
 880)                                                                   
    880.5270                           Neonatal Eye Pad                 
                                       FOK--Pad, Neonatal Eye           
    880.5420                           Pressure Infusor for an I.V. Bag 
                                       KZD--Infusor, Pressure, for I.V. 
                                        Bags                            
    880.5680                           Pediatric Position Holder        
                                       FRP--Holder, Infant Position     
    880.6250                           Patient Examination Glove        
                                       LZB--Finger Cot                  
                                       FMC--Glove, Patient Examination  
                                       LYY--Glove, Patient Examination, 
                                        Latex                           
                                       LZA--Glove, Patient Examination, 
                                        Poly                            
                                       LZC--Glove, Patient Examination, 
                                        Speciality                      
                                       LYZ--Glove, Patient Examination, 
                                        Vinyl                           
    880.6375                           Patient Lubricant                
                                       KMJ--Lubricant, Patient          
    880.6760                           Protective Restraint             
                                       BRT--Restraint, Patient,         
                                        Conductive                      
                                       FMQ--Restraint, Protective       
Neurology Panel (21 CFR Part 882)                                       
    882.1030                           Ataxiagraph                      
                                       GWW--Ataxiagraph                 
    882.1420                           Electroencephalogram (EEG) Signal
                                        Spectrum Analyzer               
                                       GWS--Analyzer, Spectrum,         
                                        Electroencephalogram Signal     

[[Page 17757]]

                                                                        
    882.4060                           Ventricular Cannula              
                                       HCD--Cannula, Ventricular        
    882.4545                           Shunt System Implantation        
                                        Instrument                      
                                       GYK--Instrument, Shunt System    
                                        Implantation                    
    882.4650                           Neurosurgical Suture Needle      
                                       HAS--Needle, Neurosurgical Suture
    882.4750                           Skull Punch                      
                                       GXJ--Punch, Skull                
Obstetrics and Gynecology Panel                                         
    (None)                                                              
Ophthalmology Panel (21 CFR Part 886)                                   
    886.1780                           Retinoscope                      
                                       HKM--Retinoscope, Battery-Powered
    886.1940                           Tonometer Sterilizer             
                                       HKZ--Sterilizer, Tonometer       
    886.4070                           Powered Corneal Burr             
                                       HQS--Burr, Corneal, AC-Powered   
                                       HOG--Burr, Corneal, Battery-     
                                        Powered                         
                                       HRG--Engine, Trephine,           
                                        Accessories, AC-Powered         
                                       HFR--Engine, Trephine,           
                                        Accessories, Battery-Powered    
                                       HLD--Engine, Trephine,           
                                        Accessories, Gas-Powered        
    886.4370                           Keratome                         
                                       HNO--Keratome, AC-Powered        
                                       HMY--Keratome, Battery-Powered   
    886.5850                           Sunglasses (Nonprescription)     
                                       HQY--Sunglasses (Nonprescription 
                                        Including Photosensitive)       
Orthopedic Panel (21 CFR Part 888)                                      
    888.1500                           Goniometer                       
                                       KQX--Goniometer, AC-Powered      
    888.4150                           Calipers for Clinical Use        
                                       KTZ--Caliper                     
Physical Medicine Panel (21 CFR Part                                    
 890)                                                                   
    890.3850                           Mechanical Wheelchair            
                                       LBE--Stroller, Adaptive          
                                       IOR--Wheelchair, Mechanical      
    890.5180                           Manual Patient Rotation Bed      
                                       INY--Bed, Patient Rotation,      
                                        Manual                          
    890.5710                           Hot or Cold Disposable Pack      
                                       IMD--Pack, Hot or Cold,          
                                        Disposable                      
Radiology Panel (21 CFR Part 892)                                       
    892.1100                           Scintillation (Gamma) Camera     
                                       IYX--Camera, Scintillation       
                                        (Gamma)                         
    892.1110                           Positron Camera                  
                                       IZC--Camera, Positron            
    892.1300                           Nuclear Rectilinear Scanner      
                                       IYW--Scanner, Rectilinear,       
                                        Nuclear                         
    892.1320                           Nuclear Uptake Probe             
                                       IZD--Probe, Uptake, Nuclear      
    892.1330                           Nuclear Whole Body Scanner       
                                       JAM--Scanner, Whole Body, Nuclear
    892.1410                           Nuclear Electrocardiograph       
                                        Synchronizer                    
                                       IVY--Synchronizer,               
                                        Electrocardiograph, Nuclear     
    892.1890                           Radiographic Film Illuminator    
                                       IXC--Illuminator, Radiographic-  
                                        Film                            
                                        JAG--Illuminator, Radiographic- 
                                        Film, Explosion-Proof           
    892.1910                           Radiographic Grid                
                                       IXJ--Grid, Radiographic          
    892.1960                           Radiographic Intensifying Screen 
                                       WAM--Screen, Intensifying,       
                                        Radiographic                    
    892.1970                           Radiographic ECG/Respirator      
                                        Synchronizer                    
                                       IXO--Synchronizer, ECG/          
                                        Respirator, Radiographic        
    892.5650                           Manual Radionuclide Applicator   
                                        System                          
                                       IWG--System, Applicator,         
                                        Radionuclide, Manual            
General and Plastic Surgery Panel (21                                   
 CFR Part 878)                                                          
     878.4200                          Introduction/Drainage Catheter   
                                        and Accessories                 
                                       KGZ--Accessories, Catheter       
                                       GCE--Adaptor, Catheter           
                                       FGY--Cannula, Injection          
                                       GBA--Catheter, Balloon Type      

[[Page 17758]]

                                                                        
                                       GBZ--Catheter, Cholangiography   
                                       GBQ--Catheter, Continuous        
                                        Irrigation                      
                                       GBY--Catheter, Eustachian,       
                                        General & Plastic Surgery       
                                       JCY--Catheter, Infusion          
                                       GBX--Catheter, Irrigation        
                                       GBP--Catheter, Multiple Lumen    
                                       GBO--Catheter, Nephrostomy,      
                                        General & Plastic Surgery       
                                       GBN--Catheter, Pediatric, General
                                        & Plastic Surgery               
                                       GBW--Catheter, Peritoneal        
                                       GBS--Catheter, Ventricular,      
                                        General & Plastic Surgery       
                                       GCD--Connector, Catheter         
                                       GCC--Dilator, Catheter           
                                       GCB--Needle, Catheter            
    878.4320                           Removable Skin Clip              
                                       FZQ--Clip, Removable (Skin)      
    878.4460                           Surgeon's Gloves                 
                                       KGO--Surgeon's Gloves            
    878.4680                           Nonpowered, Single Patient,      
                                        Portable Suction Apparatus      
                                       GCY--Apparatus, Suction, Single  
                                        Patient Use, Portable,          
                                        Nonpowered                      
    878.4760                           Removable Skin Staple            
                                       GDT--Staple, Removable (Skin)    
    878.4820                           AC-Powered, Battery-Powered, and 
                                        Pneumatically Powered Surgical  
                                        Instrument Motors and           
                                        Accessories/Attachments         
                                       GFG--Bit, Surgical               
                                       GFA--Blade, Saw, General &       
                                        Plastic Surgery                 
                                       DWH--Blade, Saw, Surgical,       
                                        Cardiovascular                  
                                       BRZ--Board, Arm (With Cover)     
                                       GFE--Brush, Dermabrasion         
                                       GFF--Bur, Surgical, General &    
                                        Plastic Surgery                 
                                       KDG--Chisel (Osteotome)          
                                       GFD--Dermatome                   
                                       GFC--Driver, Surgical, Pin       
                                       GFB--Head, Surgical, Hammer      
                                       GEY--Motor, Surgical Instrument, 
                                        AC-Powered                      
                                       GET--Motor, Surgical Instrument, 
                                        Pneumatic Powered               
                                       DWI--Saw, Electrically Powered   
                                       KFK--Saw, Pneumatically Powered  
                                       HAB--Saw, Powered, and           
                                        Accessories                     
    878.4960                           Air or AC-Powered Operating Table
                                        and Air or AC-Powered Operating 
                                        Chair & Accessories             
                                       GBB--Chair, Surgical, AC-Powered 
                                       FQO--Table, Operating-Room, AC-  
                                        Powered                         
                                       GDC--Table, Operating-Room,      
                                        Electrical                      
                                        FWW--Table, Operating-Room,     
                                        Pneumatic                       
                                       JEA--Table, Surgical with        
                                        Orthopedic Accessories, AC-     
                                        Powered                         
    880.5090                           Liquid Bandage                   
                                       KMF--Bandage, Liquid             
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other     
  medical device identifiers may be viewed on FDA's Internet Web Site at
  ``http://www.fda.gov/cdrh/prodcode.html''.                            


Table 2.--Class II Medical Devices Included in Scope of Product Coverage
  at Beginning of Transition Period (United States to develop guidance  
 documents identifying U.S. requirements and European Community (EC) to 
          identify standards needed to meet EC requirements)\1\         
------------------------------------------------------------------------
     Panel        21 CFR Section              Regulation Name           
----------------        No.       --------------------------------------
                ------------------                                      
                                         Product Code--Device Name      
------------------------------------------------------------------------
    RA           892.1000          Magnetic Resonance Diagnostic Device 
                                   MOS--COIL, Magnetic Resonance,       
                                    Specialty                           
                                   LNH--System, Nuclear Magnetic        
                                    Resonance Imaging                   
                                   LNI--System, Nuclear Magnetic        
                                    Resonance Spectroscopic             
Diagnostic                                                              
 Ultrasound:                                                            
    RA           892.1540          Nonfetal Ultrasonic Monitor          
                                   JAF--Monitor, Ultrasonic, Nonfetal   
    RA           892.1550          Ultrasonic Pulsed Doppler Imaging    
                                    System                              
                                   IYN--System, Imaging, Pulsed Doppler,
                                    Ultrasonic                          

[[Page 17759]]

                                                                        
    RA           892.1560          Ultrasonic Pulsed Echo Imaging System
                 ................  IYO--System, Imaging, Pulsed Echo,   
                                    Ultrasonic                          
    RA           892.1570          Diagnostic Ultrasonic Transducer     
                 ................  ITX--Transducer, Ultrasonic,         
                                    Diagnostic                          
Diagnostic X-                                                           
 Ray Imaging                                                            
 Devices                                                                
 (except                                                                
 mammographic x-                                                        
 ray systems):                                                          
    RA           892.1600          Angiographic X-Ray System            
                                   IZI--System, X-Ray, Angiographic     
    RA           892.1650          Image-Intensified Fluoroscopic X-Ray 
                                    System                              
                                   MQB--Solid State X-Ray Imager (Flat  
                                    Panel/Digital Imager)               
                                   JAA--System, X-Ray, Fluoroscopic,    
                                    Image-Intensified                   
    RA           892.1680          Stationary X-Ray System              
                                   KPR--System, X-Ray, Stationary       
    RA           892.1720          Mobile X-Ray System                  
                                   IZL--System, X-Ray, Mobile           
    RA           892.1740          Tomographic X-Ray System             
                                   IZF--System, X-Ray, Tomographic      
    RA           892.1750          Computed Tomography X-Ray System     
                                   JAK--System, X-Ray, Tomography,      
                                    Computed                            
ECG-Related                                                             
 Devices:                                                               
    CV           870.2340          Electrocardiograph                   
                 ................  DPS--Electrocardiograph              
                 ................  MLC--Monitor, ST Segment             
    CV           870.2350          Electrocardiograph Lead Switching    
                                    Adaptor                             
                                   DRW--Adaptor, Lead Switching,        
                                    Electrocardiograph                  
    CV           870.2360          Electrocardiograph Electrode         
                                   DRX--Electrode, Electrocardiograph   
    CV           870.2370          Electrocardiograph Surface Electrode 
                                    Tester                              
                                   KRC--Tester, Electrode, Surface,     
                                    Electrocardiographic                
    NE           882.1400          Electroencephalograph                
                                   GWQ--Electroencephalograph           
    HO           880.5725          Infusion Pump (external only)        
                                   MRZ--Accessories, Pump, Infusion     
                                   FRN--Pump, Infusion                  
                                   LZF--Pump, Infusion, Analytical      
                                    Sampling                            
                                   MEB--Pump, Infusion, Elastomeric     
                                   LZH--Pump, Infusion, Enteral         
                                   MHD--Pump, Infusion, Gallstone       
                                    Dissolution                         
                                   LZG--Pump, Infusion, Insulin         
                                   MEA--Pump, Infusion, PCA             
Ophthalmic                                                              
 Instruments:                                                           
    OP            886.1570         Ophthalmoscope                       
                                   HLI--Ophthalmoscope, AC-Powered      
                                   HLJ--Ophthalmoscope, Battery-Powered 
    OP           886.1780          Retinoscope                          
                                   HKL--Retinoscope, AC-Powered         
    OP           886.1850          AC-Powered Slit-Lamp Biomicroscope   
                                   HJO--Biomicroscope, Slit-Lamp, AC-   
                                    Powered                             
    OP           886.4150          Vitreous Aspiration and Cutting      
                                    Instrument                          
                                   MMC--Dilator, Expansive Iris         
                                    (Accessory)                         
                                   HQE--Instrument, Vitreous Aspiration 
                                    and Cutting, AC-Powered             
                                   HKP--Instrument, Vitreous Aspiration 
                                    and Cutting, Battery-Powered        
                                   MLZ--Vitrectomy, Instrument Cutter   
    OP           886.4670          Phacofragmentation System            
                                   HQC--Unit, Phacofragmentation        
    SU           878.4580          Surgical Lamp                        
                                   HBI--Illuminator, Fiberoptic,        
                                    Surgical Field                      
                                   FTF--Illuminator, Nonremote          
                                   FTG--Illuminator, Remote             
                                   HJE--Lamp, Fluorescein, AC-Powered   
                                   FQP--Lamp, Operating-Room            
                                   FTD--Lamp, Surgical                  
                                   GBC--Lamp, Surgical, Incandescent    
                                   FTA--Light, Surgical, Accessories    
                                   FSZ--Light, Surgical, Carrier        
                                   FSY--Light, Surgical, Ceiling Mounted

[[Page 17760]]

                                                                        
                                   FSX--Light, Surgical, Connector      
                                   FSW--Light, Surgical, Endoscopic     
                                   FST--Light, Surgical, Fiberoptic     
                                   FSS--Light, Surgical, Floor Standing 
                                   FSQ--Light, Surgical, Instrument     
    NE           882.5890          Transcutaneous Electrical Nerve      
                                    Stimulator for Pain Relief          
                                   GZJ--Stimulator, Nerve,              
                                    Transcutaneous, For Pain Relief     
                                   Noninvasive Blood Pressure           
                                    Measurement Devices:                
    CV           870.1120          Blood Pressure Cuff                  
                                   DXQ--Cuff, Blood-Pressure            
    CV           870.1130          Noninvasive Blood Pressure           
                                    Measurement System (except          
                                    nonoscillometric)                   
                                   DXN--System, Measurement, Blood-     
                                    Pressure, Noninvasive               
    HO           880.6880          Steam Sterilizer (greater than 2     
                                    cubic feet)                         
                                   FLE--Sterilizer, Steam               
Clinical                                                                
 Thermometers:                                                          
    HO           880.2910          Clinical Electronic Thermometer      
                                    (except tympanic or pacifier)       
                                   FLL--Thermometer, Electronic,        
                                    Clinical                            
    AN           868.5630          Nebulizer                            
                                   CAF--Nebulizer (Direct Patient       
                                    Interface)                          
    AN           868.5925          Powered Emergency Ventilator         
Hypodermic                                                              
 Needles and                                                            
 Syringes                                                               
 (except                                                                
 antistick and                                                          
 self-                                                                  
 destruct):                                                             
    HO           880.5570          Hypodermic Single Lumen Needle       
                                   MMK--Container, Sharpes              
                                   FMI--Needle, Hypodermic, Single Lumen
                                   MHC--Port, Intraosseous, Implanted   
    HO           880.5860          Piston Syringe                       
                                   FMF--Syringe, Piston                 
    OR           888.3020          Intramedullary Fixation Rod          
                                   HSB--ROD, Fixation, Intramedullary   
                                    and Accessories                     
External                                                                
 Fixators                                                               
 (except                                                                
 devices with                                                           
 no external                                                            
 components):                                                           
    OR           888.3030          Single/Multiple Component Metallic   
                                    Bone Fixation Appliances and        
                                    Accessories                         
                                   KTT--Appliance, Fixation, Nail/Blade/
                                    Plate Combination, Multiple         
                                    Component                           
    OR           888.3040          Smooth or Threaded Metallic Bone     
                                    Fixation Fastener                   
                                   JEC--Component, Traction, Invasive   
                                   HTY--Pin, Fixation, Smooth           
                                   JDW--Pin, Fixation, Threaded         
Selected Dental                                                         
 Materials:                                                             
    DE           872.3060          Gold-Based Alloys and Precious Metal 
                                    Alloys for Clinical Use             
                                   EJT--Alloy, Gold Based, For Clinical 
                                    Use                                 
                                   EJS--Alloy, Precious Metal, For      
                                    Clinical Use                        
    DE           872.3200          Resin Tooth Bonding Agent            
                                    KLE--Agent, Tooth Bonding, Resin    
    DE           872.3275          Dental Cement                        
                                   EMA--Cement, Dental                  
                                   EMB--Zinc Oxide Eugenol              
    DE           872.3660          Impression Material                  
                                   ELW--Material, Impression            
    DE           872.3690          Tooth Shade Resin Material           
                                   EBF--Material, Tooth Shade, Resin    
    DE            872.3710         Base Metal Alloy                     
                                   EJH--Metal, Base                     
Latex Condoms:                                                          
    OB           884.5300          Condom                               
                                   HIS--Condom                          
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other     
  medical device identifiers may be viewed on FDA's Internet Web Site at
  ``http://www.fda.gov/cdrh/prodcode.html''.                            


[[Page 17761]]


  Table 3.--Medical Devices for Possible Inclusion in Scope of Product  
                  Coverage During Operational Period\1\                 
------------------------------------------------------------------------
  Product Family   21 CFR Section No     Device Name          Tier      
------------------------------------------------------------------------
Anesthesiology                                                          
 Panel                                                                  
    Anesthesia     868.5160           Gas machine for   2               
     Devices                           anesthesia or                    
                                       analgesia                        
                   868.5270           Breathing system  2               
                                       heater                           
                   868.5440           Portable oxygen   2               
                                       generator                        
                   868.5450           Respiratory gas   2               
                                       humidifier                       
                   868.5630           Nebulizer         2               
                   868.5710           Electrically       2              
                                       powered oxygen                   
                                       tent                             
                   868.5880           Anesthetic        2               
                                       vaporizer                        
    Gas Analyser   868.1040           Powered           2               
                                       Algesimeter                      
                   868.1075           Argon gas         2               
                                       analyzer                         
                   868.1400           Carbon dioxide    2               
                                       gas analyzer                     
                   868.1430           Carbon monoxide   2               
                                       gas analyzer                     
                   868.1500           Enflurane gas     2               
                                       analyzer                         
                   868.1620           Halothane gas     2               
                                       analyzer                         
                   868.1640           Helium gas        2               
                                       analyzer                         
                   868.1670           Neon gas          2               
                                       analyzer                         
                   868.1690           Nitrogen gas      2               
                                       analyzer                         
                   868.1700           Nitrous oxide     2               
                                       gas analyzer                     
                   868.1720           Oxygen gas        2               
                                       analyzer                         
                   868.1730           Oxygen uptake     2               
                                       computer                         
    Peripheral     868.2775           Electrical        2               
     Nerve                             peripheral                       
     Stimulators                       nerve                            
                                       stimulator                       
    Respiratory    868.1750           Pressure          2               
     Monitoring                        plethysmograph                   
                   868.1760           Volume            2               
                                       plethysmograph                   
                   868.1780           Inspiratory       2               
                                       airway pressure                  
                                       meter                            
                   868.1800           Rhinoanemometer   2               
                   868.1840           Diagnostic        2               
                                       spirometer                       
                   868.1850           Monitoring        2               
                                       spirometer                       
                   868.1860           Peak-flow meter   2               
                                       for spirometry                   
                   868.1880           Pulmonary-        2               
                                       function data                    
                                       calculator                       
                   868.1890           Predictive        2               
                                       pulmonary-                       
                                       function value                   
                                       calculator                       
                   868.1900           Diagnostic        2               
                                       pulmonary-                       
                                       function                         
                                       interpretation                   
                                       calculator                       
                   868.2025           Ultrasonic air    2               
                                       embolism                         
                                       monitor                          
                   868.2375           Breathing         2               
                                       frequency                        
                                       monitor (except                  
                                       apnea                            
                                       detectors)                       
                   868.2480           Cutaneous carbon  2               
                                       dioxide (PcCO2)                  
                                       monitor                          
                   868.2500           Cutaneous oxygen  2               
                                       monitor (for an                  
                                       infant not                       
                                       under gas                        
                                       anesthesia)                      
                   868.2550           Pneumotachomomet  2               
                                       er                               
                   868.2600           Airway pressure   2               
                                       monitor                          
                   868.5665           Powered           2               
                                       percussor                        
                   868.5690           Incentive         2               
                                       spirometer                       
    Ventilator     868.5905           Noncontinuous     2               
                                       ventilator                       
                                       (IPPB)                           
                   868.5925           Powered           2               
                                       emergency                        
                                       ventilator                       
                   868.5935           External          2               
                                       negative                         
                                       pressure                         
                                       ventilator                       
                   868.5895           Continuous        2               
                                       ventilator                       
                   868.5955           Intermittent      2               
                                       mandatory                        
                                       ventilation                      
                                       attachment                       
                   868.6250           Portable air      2               
                                       compressor                       
Cardiovascular                                                          
 Panel                                                                  
    Cardiovascula  870.1425           Programmable      2               
     r Diagnostic                      diagnostic                       
                                       computer                         
                   870.1450           Densitometer      2               
                   870.2310           Apex cardiograph  2               
                                       (vibrocardiogra                  
                                       ph)                              
                   870.2320           Ballistocardiogr  2               
                                       aph                              
                   870.2340           Electrocardiogra  2               
                                       ph                               
                   870.2350           Electrocardiogra  1               
                                       ph lead                          
                                       switching                        
                                       adaptor                          
                   870.2360           Electrocardiogra  2               
                                       ph electrode                     
                   870.2370           Electrocardiogra  2               
                                       ph surface                       
                                       electrode                        
                                       tester                           
                   870.2400           Vectorcardiograp  1               
                                       h                                
                   870.2450           Medical cathode-  1               
                                       ray tube                         
                                       display                          

[[Page 17762]]

                                                                        
                   870.2675           Oscillometer      2               
                   870.2840           Apex              2               
                                       cardiographic                    
                                       transducer                       
                   870.2860           Heart sound       2               
                                       transducer                       
    Cardiovascula                     Valve, pressure                   
     r Monitoring                      relief,                          
                                       cardiopulmonary                  
                                       bypass                           
                   870.1100           Blood pressure    2               
                                       alarm                            
                   870.1110           Blood pressure    2               
                                       computer                         
                   870.1120           Blood pressure    2               
                                       cuff                             
                   870.1130           Noninvasive       2               
                                       blood pressure                   
                                       measurement                      
                                       system                           
                   870.1140           Venous blood      2               
                                       pressure                         
                                       manometer                        
                   870.1220           Electrode         2               
                                       recording                        
                                       catheter or                      
                                       electrode                        
                                       recording probe                  
                   870.1270           Intracavitary     2               
                                       phonocatheter                    
                                       system                           
                   870.1875           Stethoscope       2               
                                       (electronic)                     
                   870.2050           Biopotential      2               
                                       amplifier and                    
                                       signal                           
                                       conditioner                      
                   870.2060           Transducer        2               
                                       signal                           
                                       amplifier and                    
                                       conditioner                      
                   870.2100           Cardiovascular    2               
                                       blood flow-                      
                                       meter                            
                   870.2120           Extravascular     2               
                                       blood flow                       
                                       probe                            
                   870.2300           Cardiac monitor   2               
                                       (including                       
                                       cardiotachomete                  
                                       r and rate                       
                                       alarm)                           
                   870.2700           Oximeter          2               
                   870.2710           Ear oximeter      2               
                   870.2750           Impedance         2               
                                       phlebograph                      
                   870.2770           Impedance         2               
                                       plethysmograph                   
                   870.2780           Hydraulic,        2               
                                       pneumatic, or                    
                                       photoelectric                    
                                       plethysmographs                  
                   870.2850           Extravascular     2               
                                       blood pressure                   
                                       transducer                       
                   870.2870           Catheter tip      2               
                                       pressure                         
                                       transducer                       
                   870.2880           Ultrasonic        2               
                                       transducer                       
                   870.2890           Vessel occlusion  2               
                                       transducer                       
                   870.2900           Patient           2               
                                       transducer and                   
                                       electrode cable                  
                                       (including                       
                                       connector)                       
                   870.2910           Radiofrequency    2               
                                       physiological                    
                                       signal                           
                                       transmitter and                  
                                       receiver                         
                   870.2920           Telephone         2               
                                       electrocardiogr                  
                                       aph transmitter                  
                                       and receiver                     
                   870.4205           Cardiopulmonary   2               
                                       bypass bubble                    
                                       detector                         
                   870.4220           Cardiopulmonary   2               
                                       bypass heart-                    
                                       lung machine                     
                                       console                          
                   870.4240           Cardiovascular    2               
                                       bypass heat                      
                                       exchanger                        
                   870.4250           Cardiopulmonary   2               
                                       bypass                           
                                       temperature                      
                                       controller                       
                   870.4300           Cardiopulmonary   2               
                                       bypass gas                       
                                       control unit                     
                   870.4310           Cardiopulmonary   2               
                                       bypass coronary                  
                                       pressure gauge                   
                   870.4330           Cardiopulmonary   2               
                                       bypass on-line                   
                                       blood gas                        
                                       monitor                          
                   870.4340           Cardiopulmonary   2               
                                       bypass level                     
                                       sensing monitor                  
                                       and/or control                   
                   870.4370           Roller-type       2               
                                       cardiopulmonary                  
                                       bypass blood                     
                                       pump                             
                   870.4380           Cardiopulmonary   2               
                                       bypass pump                      
                                       speed control                    
                   870.4410           Cardiopulmonary   2               
                                       bypass in-line                   
                                       blood gas                        
                                       sensor                           
    Cardiovascula  870.5050           Patient care      2               
     r                                 suction                          
     Therapeutic                       apparatus                        
                   870.5900           Thermal           2               
                                       regulation                       
                                       system                           
    Defibrillator  870.5300           DC-               2               
                                       defribrillator                   
                                       (including                       
                                       paddles)                         
                   870.5325           Defibrillator     2               
                                       tester                           

[[Page 17763]]

                                                                        
    Echocardiogra  870.2330           Echocardiograph   2               
     ph                                                                 
    Pacemaker &    870.1750           External          2               
     Accessories                       programmable                     
                                       pacemaker pulse                  
                                       generator                        
                   870.3630           Pacemaker         2               
                                       generator                        
                                       function                         
                                       analyzer                         
                   870.3640           Indirect          2               
                                       pacemaker                        
                                       generator                        
                                       function                         
                                       analyzer                         
                   870.3720           Pacemaker         2               
                                       electrode                        
                                       function tester                  
    Miscellaneous  870.1800           Withdrawal-       2               
                                       infusion pump                    
                   870.2800           Medical magnetic  2               
                                       tape recorder                    
                   None               Batteries,                        
                                       rechargeable,                    
                                       class II                         
                                       devices                          
Dental Panel                                                            
    Dental         872.1720           Pulp tester       2               
     Equipment                                                          
                   872.1740           Caries detection  2               
                                       device                           
                   872.4120           Bone cutting      2               
                                       instrument and                   
                                       accessories                      
                   872.4465           Gas-powered jet   2               
                                       injector                         
                   872.4475           Spring-powered    2               
                                       jet injector                     
                   872.4600           Intraoral         2               
                                       ligature and                     
                                       wire lock                        
                   872.4840           Rotary scaler     2               
                   872.4850           Ultrasonic        2               
                                       scaler                           
                   872.4920           Dental            2               
                                       electrosurgical                  
                                       unit and                         
                                       accessories                      
                   872.6070           Ultraviolet       2               
                                       activator for                    
                                       polymerization                   
                   872.6350           Ultraviolet       2               
                                       detector                         
    Dental         872.3050           Amalgam alloy     2               
     Material                                                           
                   872.3060           Gold-based        2               
                                       alloys and                       
                                       precious metal                   
                                       alloys for                       
                                       clinical use                     
                   872.3200           Resin tooth       2               
                                       bonding agent                    
                   872.3250           Calcium           2               
                                       hydroxide                        
                                       cavity liner                     
                   872.3260           Cavity varnish    2               
                   872.3275           Dental cement     2               
                                       (other than                      
                                       zinc oxide-                      
                                       eugenol)                         
                   872.3300           Hydrophilic       2               
                                       resin coating                    
                                       for dentures                     
                   872.3310           Coating material  2               
                                       for resin                        
                                       fillings                         
                   872.3590           Preformed         2               
                                       plastic denture                  
                                       tooth                            
                   872.3660           Impression        2               
                                       material                         
                   872.3690           Tooth shade       2               
                                       resin material                   
                   872.3710           Base metal alloy  2               
                   872.3750           Bracket adhesive  2               
                                       resin and tooth                  
                                       conditioner                      
                   872.3760           Denture           2               
                                       relining,                        
                                       repairing, or                    
                                       rebasing resin                   
                   872.3765           Pit and fissure   2               
                                       sealant and                      
                                       conditioner                      
                   872.3770           Temporary crown   2               
                                       and bridge                       
                                       resin                            
                   872.3820           Root canal        2               
                                       filling resin                    
                                       (other than                      
                                       chloroform use)                  
                   872.3920           Porcelain tooth   2               
    Dental X-ray   872.1800           Extraoral source  2               
                                       x-ray system                     
                   872.1810           Intraoral source  2               
                                       x-ray system                     
     Dental        872.4880           Intraosseous      2               
     Implants                          fixation screw                   
                                       or wire                          
                   872.3890           Endodontic        2               
                                       stabilizing                      
                                       splint                           
    Orthodontic    872.5470           Orthodontic       2               
                                       plastic bracket                  
Ear/Nose/Throat                                                         
 Panel                                                                  
    Diagnostic     874.1050           Audiometer        2               
     Equipment                                                          
                   874.1090           Auditory          2               
                                       impedance                        
                                       tester                           
                   874.1120           Electronic noise  2               
                                       generator for                    
                                       audiometric                      
                                       testing                          
                   874.1325           Electroglottogra  2               
                                       ph                               
                   874.1820           Surgical nerve    2               
                                       stimulator/                      
                                       locator                          
    Hearing Aids   874.3300           Hearing aid (for  2               
                                       bone-                            
                                       conduction)                      
                   874.3310           Hearing aid       2               
                                       calibrator and                   
                                       analysis system                  
                   874.3320           Group hearing     2               
                                       aid or group                     
                                       auditory                         
                                       trainer                          

[[Page 17764]]

                                                                        
                   874.3330           Master hearing    2               
                                       aid                              
    Surgical       874.4250           Ear, nose, and    1               
     Equipment                         throat electric                  
                                       or pneumatic                     
                                       surgical drill                   
                   874.4490           Argon laser for   2               
                                       otology,                         
                                       rhinology, and                   
                                       laryngology                      
                   874.4500           Ear, nose, and    2               
                                       throat                           
                                       microsurgical                    
                                       carbon dioxide                   
                                       laser                            
Gastroenterology/                                                       
 Urology Panel                                                          
    Endoscope      876.1500           Endoscope and     2               
     (including                        accessories                      
     angioscopes,                                                       
     laparscopes,                                                       
     ophthalmic                                                         
     endoscopes)                                                        
                   876.4300           Endoscopic        2               
                                       electrosurgical                  
                                       unit and                         
                                       accessories                      
    Gastroenterol  876.1725           Gastrointestinal  1               
     ogy                               motility                         
                                       monitoring                       
                                       system                           
    Hemodialysis   876.5600           Sorbent           2               
                                       regenerated                      
                                       dialysate                        
                                       delivery system                  
                                       for                              
                                       hemodialysis                     
                   876.5630           Peritoneal        2               
                                       dialysis system                  
                                       and accessories                  
                   876.5665           Water             2               
                                       purification                     
                                       system for                       
                                       hemodialysis                     
                   876.5820            Hemodialysis     2               
                                       system and                       
                                       accessories                      
                   876.5830           Hemodialyzer      2               
                                       with disposable                  
                                       insert (kiil-                    
                                       type)                            
    Lithotriptor   876.4500           Mechanical        2               
                                       lithotriptor                     
    Urology        876.1620           Urodynamics       2               
     Equipment                         measurement                      
                                       system                           
                   876.5320           Nonimplanted      2               
                                       electrical                       
                                       continence                       
                                       device                           
                   876.5880           Isolated kidney   2               
                                       perfusion and                    
                                       transport                        
                                       system and                       
                                       accessories                      
General Hospital                                                        
 Panel                                                                  
    Infusion       880.2420           Electronic        2               
     Pumps and                         monitor for                      
     Systems                           gravity flow                     
                                       infusion                         
                                       systems                          
                   880.2460           Electrically      2               
                                       powered spinal                   
                                       fluid pressure                   
                                       monitor                          
                   880.5430           Nonelectrically   2               
                                       powered fluid                    
                                       injector                         
                   880.5725           Infusion pump     2               
    Neonatal       880.5400           Neonatal          2               
     Incubators                        incubator                        
                   880.5410           Neonatal          2               
                                       transport                        
                                       incubator                        
                   880.5700           Neonatal          2               
                                       phototherapy                     
                                       unit                             
    Piston         880.5570           Hypodermic        1               
     Syringes                          single lumen                     
                                       needle                           
                   880.5860           Piston syringe    1               
                                       (except                          
                                       antistick)                       
                   880.6920           Syringe needle    2               
                                       introducer                       
    Miscellaneous  880.2910           Clinical          2               
                                       electronic                       
                                       thermometer                      
                   880.2920           Clinical mercury  2               
                                       thermometer                      
                   880.5100           AC-powered        1               
                                       adjustable                       
                                       hospital bed                     
                   880.5500           AC-powered        2               
                                       patient lift                     
                   880.6880           Steam sterilizer  2               
                                       (greater than 2                  
                                       cubic feet)                      
Neurology Panel                                                         
                   882.1020           Rigidity          2               
                                       analyzer                         
                   882.1610           Alpha monitor     2               
    Neuro-         882.1320           Cutaneous         2               
     Diagnostic                        electrode                        
                   882.1340           Nasopharyngeal    2               
                                       electrode                        
                   882.1350           Needle electrode  2               
                   882.1400           Electroencephalo  2               
                                       graph                            
                   882.1460           Nystagmograph     2               
                   882.1480           Neurological      2               
                                       endoscope                        
                   882.1540           Galvanic skin     2               
                                       response                         
                                       measurement                      
                                       device                           
                   882.1550           Nerve conduction  2               
                                       velocity                         
                                       measurement                      
                                       device                           
                   882.1560           Skin potential    2               
                                       measurement                      
                                       device                           
                   882.1570           Powered direct-   2               
                                       contact                          
                                       temperature                      
                                       measurement                      
                                       device                           

[[Page 17765]]

                                                                        
                   882.1620           Intracranial      2               
                                       pressure                         
                                       monitoring                       
                                       device                           
                   882.1835           Physiological     2               
                                       signal                           
                                       amplifier                        
                   882.1845           Physiological     2               
                                       signal                           
                                       conditioner                      
                   882.1855           Electroencephalo  2               
                                       gram (EEG)                       
                                       telemetry                        
                                       system                           
                   882.5050           Biofeedback       2               
                                       device                           
    Echoencephalo  882.1240           Echoencephalogra  2               
     graphy                            ph                               
    RPG            882.4400           Radiofrequency    2               
                                       lesion                           
                                       generator                        
    Neuro Surgery  none               Electrode,        2               
                                       spinal epidural                  
                   882.4305           Powered compound  2               
                                       cranial drills,                  
                                       burrs,                           
                                       trephines, and                   
                                       their                            
                                       accessories                      
                   882.4310           Powered simple    2               
                                       cranial drills                   
                                       burrs,                           
                                       trephines, and                   
                                       their                            
                                       accessories                      
                   882.4360           Electric cranial  2               
                                       drill motor                      
                   882.4370           Pneumatic         2               
                                       cranial drill                    
                                       motor                            
                   882.4560           Stereotaxic       2               
                                       instrument                       
                   882.4725           Radiofrequency    2               
                                       lesion probe                     
                   882.4845           Powered rongeur   2               
                   882.5500           Lesion            2               
                                       temperature                      
                                       monitor                          
    Stimulators    882.1870           Evoked response   2               
                                       electrical                       
                                       stimulator                       
                   882.1880           Evoked response   2               
                                       mechanical                       
                                       stimulator                       
                   882.1890           Evoked response   2               
                                       photic                           
                                       stimulator                       
                   882.1900           Evoked response   2               
                                       auditory                         
                                       stimulator                       
                   882.1950           Tremor            2               
                                       transducer                       
                   882.5890           Transcutaneous    2               
                                       electrical                       
                                       nerve                            
                                       stimulator for                   
                                       pain relief                      
Obstetrics/                                                             
 Gynecology Panel                                                       
    Fetal          884.1660           Transcervical     2               
     Monitoring                        endoscope                        
                                       (amnioscope)                     
                                       and accessories                  
                   884.1690           Hysteroscope and  2               
                                       accessories                      
                                       (for                             
                                       performance                      
                                       standards)                       
                   884.2225           Obstetric-        2               
                                       gynecologic                      
                                       ultrasonic                       
                                       imager                           
                   884.2600           Fetal cardiac     2               
                                       monitor                          
                   884.2640           Fetal             2               
                                       phonocardiograp                  
                                       hic monitor and                  
                                       accessories                      
                   884.2660           Fetal ultrasonic  2               
                                       monitor and                      
                                       accessories                      
                   884.2675           Fetal scalp       1               
                                       circular                         
                                       (spiral)                         
                                       electrode and                    
                                       applicator                       
                   884.2700           Intrauterine      2               
                                       pressure                         
                                       monitor and                      
                                       accessories                      
                   884.2720           External uterine  2               
                                       contraction                      
                                       monitor and                      
                                       accessories                      
                   884.2740           Perinatal         2               
                                       monitoring                       
                                       system and                       
                                       accessories                      
                   884.2960           Obstetric         2               
                                       ultrasonic                       
                                       transducer and                   
                                       accessories                      
    Gynecological  884.1720           Gynecologic       2               
     Surgery                           laparoscope and                  
     Equipment                         accessories                      
                   884.4160           Unipolar          2               
                                       endoscopic                       
                                       coagulator-                      
                                       cutter and                       
                                       accessories                      
                   884.4550           Gynecologic       2               
                                       surgical laser                   
                   884.4120           Gynecologic       2               
                                       electrocautery                   
                                       and accessories                  
                   884.5300           Condom            2               
    Ophthalmic     886.3320           Eye sphere        2               
     Implants                          implant                          
    Contact Lens   886.1385           Polymethylmethac  2               
                                       rylate (PMMA)                    
                                       diagnostic                       
                                       contact lens                     
                   886.5916           Rigid gas         2               
                                       permeable                        
                                       contact lens                     
                                       (daily wear                      
                                       only)                            
    Diagnostic     886.1120           Opthalmic camera  1               
     Equipment                                                          
                   886.1220           Corneal           1               
                                       electrode                        
                   886.1250           Euthyscope (AC-   1               
                                       powered)                         
                   886.1360           Visual field      1               
                                       laser                            
                                       instrument                       

[[Page 17766]]

                                                                        
                   886.1510           Eye movement      1               
                                       monitor                          
                   886.1570           Ophthalmoscope    1               
                   886.1630           AC-powered        1               
                                       photostimulator                  
                   886.1640           Ophthalmic        1               
                                       preamplifier                     
                   886.1670           Ophthalmic        2               
                                       isotope uptake                   
                                       probe                            
                   886.1780           Retinoscope (AC-  1               
                                       powered device)                  
                   886.1850           AC-powered slit   1               
                                       lamp                             
                                       biomicroscope                    
                   886.1930           Tonometer and     2               
                                       accessories                      
                   886.1945           Transilluminator  1               
                                       (AC-powered                      
                                       device)                          
                   886.3130           Ophthalmic        2               
                                       conformer                        
    (Diagnostic/   886.4670           Phacofragmentati  2               
     Surgery                           on system                        
     Equipment)                                                         
     Ophthalmic    886.3340           Extraocular       2               
     Implants                          orbital implant                  
                   886.3800           Scleral shell     2               
    Surgical        880.5725          Infusion pump     2               
     Equipment                         (performance                     
                                       standards)                       
                   886.3100           Ophthalmic        2               
                                       tantalum clip                    
                   886.3300           Absorbable        2               
                                       implant                          
                                       (scleral                         
                                       buckling                         
                                       method)                          
                   886.4100           Radiofrequency    2               
                                       electrosurgical                  
                                       cautery                          
                                       apparatus                        
                   886.4115           Thermal cautery   2               
                                       unit                             
                   886.4150           Vitreous          2               
                                       aspiration and                   
                                       cutting                          
                                       instrument                       
                   886.4170           Cryophthalmic     2               
                                       unit                             
                   886.4250           Ophthalmic        1               
                                       electrolysis                     
                                       unit (AC-                        
                                       powered device)                  
                   886.4335           Operating         1               
                                       headlamp (AC-                    
                                       powered device)                  
                   886.4390           Ophthalmic laser  2               
                   886.4392           Nd:YAG laser for  2               
                                       posterior                        
                                       capsulotomy                      
                   886.4400           Electronic metal  1               
                                       locator                          
                   886.4440           AC-powered        1               
                                       magnet                           
                   886.4610           Ocular pressure   2               
                                       applicator                       
                   886.4690           Ophthalmic        2               
                                       photocoagulator                  
                   886.4790           Ophthalmic        2               
                                       sponge                           
                   886.5100           Ophthalmic beta   2               
                                       radiation                        
                                       source                           
                   none               Ophthalmoscopes,  1               
                                       replacement                      
                                       batteries, hand-                 
                                       held                             
Orthopedic Panel                                                        
    Implants       888.3010           Bone fixation     2               
                                       cerclage                         
                   888.3020           Intramedullary    2               
                                       fixation rod                     
                   888.3030           Single/multiple   2               
                                       component                        
                                       metallic bone                    
                                       fixation                         
                                       appliances and                   
                                       accessories                      
                   888.3040           Smooth or         2               
                                       threaded                         
                                       metallic bone                    
                                       fixation                         
                                       fastener                         
                   888.3050           Spinal            2               
                                       interlaminal                     
                                       fixation                         
                                       orthosis                         
                   888.3060           Spinal            2               
                                       intervertebral                   
                                       body fixation                    
                                       orthosis                         
    Surgical       888.1240           AC-powered        2               
     Equipment                         dynamometer                      
                   888.4580           Sonic surgical    2               
                                       instrument and                   
                                       accessories/                     
                                       attachments                      
                   none               Accessories,      2               
                                       fixation,                        
                                       spinal                           
                                       interlaminal                     
                   none               Accessories,      2               
                                       fixation,                        
                                       spinal                           
                                       intervertebral                   
                                       body                             
                   none               Monitor,          1               
                                       pressure,                        
                                       intracompartmen                  
                                       tal                              
                   none               Orthosis,         2               
                                       fixation,                        
                                       spinal                           
                                       intervertebral                   
                                       fusion                           
                   none               Orthosis, spinal                  
                                       pedicle                          
                                       fixation                         
                   none               System, cement    1               
                                       removal                          
                                       extraction                       

[[Page 17767]]

                                                                        
Physical Medicine                                                       
 Panel                                                                  
    Diagnostic     890.1225           Chronaximeter     2               
     Equipment or                                                       
     (Therapy)                                                          
     Therapeutic                                                        
     Equipment                                                          
                   890.1375           Diagnostic        2               
                                       electromyograph                  
                   890.1385           Diagnostic        2               
                                       electromyograph                  
                                       needle                           
                                       electrode                        
                   890.1450           Powered reflex    2               
                                       hammer                           
                   890.1850           Diagnostic        2               
                                       muscle                           
                                       stimulator                       
    or (Therapy)   890.5850           Powered muscle    2               
                                       stimulator                       
    Therapeutic    890.5100           Immersion         2               
     Equipment                         hydrobath                        
                   890.5110           Paraffin bath     2               
                   890.5500           Infrared lamp     2               
                   890.5720           Water             2               
                                       circulating hot                  
                                       or cold pack                     
                   890.5740           Powered heating   2               
                                       pad                              
Radiology Panel                                                         
    MRI            892.1000           Magnetic          2               
                                       resonance                        
                                       diagnostic                       
                                       device                           
    Ultrasound     884.2660           Fetal ultrasonic  2               
     Diagnostic                        monitor and                      
                                       accessories                      
                   892.1540           Nonfetal                          
                                       ultrasonic                       
                                       monitor                          
                   892.1560           Ultrasonic        2               
                                       pulsed echo                      
                                       imaging system                   
                   892.1570           Diagnostic        2               
                                       ultrasonic                       
                                       transducer                       
                   892.1550           Ultrasonic                        
                                       pulsed doppler                   
                                       imaging system                   
    Angiographic   892.1600           Angiographic x-   2               
                                       ray system                       
    Diagnostic X-  892.1610           Diagnostic x-ray  2               
     Ray                               beam-limiting                    
                                       device                           
                   892.1620           Cine or spot      2               
                                       fluorographic x-                 
                                       ray camera                       
                   892.1630           Electrostatic x-  2               
                                       ray imaging                      
                                       system                           
                   892.1650           Image-            2               
                                       intensified                      
                                       fluoroscopic x-                  
                                       ray system                       
                   892.1670           Spot film device  2               
                   892.1680           Stationary x-ray  2               
                                       system                           
                   892.1710           Mammographic x-   2               
                                       ray system                       
                   892.1720           Mobile x-ray      2               
                                       system                           
                   892.1740           Tomographic x-    1               
                                       ray system                       
                   892.1820           Pneumoencephalog  2               
                                       raphic chair                     
                   892.1850           Radiographic      1               
                                       film cassette                    
                   892.1860           Radiographic      1               
                                       film/cassette                    
                                       changer                          
                   892.1870           Radiographic      2               
                                       film/cassette                    
                                       changer                          
                                       programmer                       
                   892.1900           Automatic         2               
                                       radiographic                     
                                       film processor                   
                   892.1980           Radiologic table  1               
    CT Scanner     892.1750           Computed          2               
                                       tomography x-                    
                                       ray system                       
    Radiation      892.5050           Medical charged-  2               
     Therapy                           particle                         
                                       radiation                        
                                       therapy system                   
                   892.5300           Medical neutron   2               
                                       radiation                        
                                       therapy system                   
                   892.5700           Remote            2               
                                       controlled                       
                                       radionuclide                     
                                       applicator                       
                                       system                           
                   892.5710           Radiation         2               
                                       therapy beam-                    
                                       shaping block                    
                   892.5730           Radionuclide      2               
                                       brachytherapy                    
                                       source                           
                   892.5750           Radionuclide      2               
                                       radiation                        
                                       therapy system                   
                   892.5770           Powered           2               
                                       radiation                        
                                       therapy patient                  
                                       support                          
                                       assembly                         
                   892.5840           Radiation         2               
                                       therapy                          
                                       simulation                       
                                       system                           
                   892.5930           Therapeutic x-    1               
                                       ray tube                         
                                       housing                          
                                       assembly                         
    Nuclear        892.1170           Bone              2               
     Medicine                          densitometer                     
                   892.1200           Emission          2               
                                       computed                         
                                       tomography                       
                                       system                           

[[Page 17768]]

                                                                        
                   892.1310           Nuclear           1               
                                       tomography                       
                                       system                           
                   892.1390           Radionuclide      2               
                                       rebreathing                      
                                       system                           
General/Plastic                                                         
 Surgery Panel                                                          
    Surgical       878.4630           Ultraviolet lamp  2               
     Lamps                             for                              
                                       dermatologic                     
                                       disorders                        
                   890.5500           Infrared lamp     2               
                   878.4580           Surgical lamp     2               
    Electrosurgic  878.4810           Laser surgical    2               
     al Cutting                        instrument for                   
     Equipment                         use in general                   
                                       and plastic                      
                                       surgery and in                   
                                       dermatology                      
                   878.4400           Electrosurgical   2               
                                       cutting and                      
                                       coagulation                      
                                       device and                       
                                       accessories                      
    Miscellaneous  878.4780           Powered suction   2               
                                       pump                             
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other     
  medical device identifiers may be viewed on FDA's Internet Web Site at
  ``http://www.fda.gov/cdrh/prodcode.html''.                            

Appendix C of Subpart B [Reserved]

Appendix D of Subpart B [Reserved]

Appendix E of Subpart B [Reserved]

Appendix F of Subpart B [Reserved]

Subpart C--Framework or ``Umbrella'' Provisions


Sec. 26.60  Definitions.

    (a) The following terms and definitions shall apply to this part 
only:
    (1) Designating Authority means a body with power to designate, 
monitor, suspend, remove suspension of, or withdraw conformity 
assessment bodies as specified under this part.
    (2) Designation means the identification by a designating authority 
of a conformity assessment body to perform conformity assessment 
procedures under this part.
    (3) Regulatory Authority means a government agency or entity that 
exercises a legal right to control the use or sale of products within a 
party's jurisdiction and may take enforcement action to ensure that 
products marketed within its jurisdiction comply with legal 
requirements.
    (b) Other terms concerning conformity assessment used in this part 
shall have the meaning given elsewhere in this part or in the 
definitions contained in Guide 2 (1996 edition) of the International 
Organization for Standardization (ISO) and the International 
Electrotechnical Commission (IEC). In the event of an inconsistency 
between the ISO/IEC Guide 2 and definitions in this part, the 
definitions in this part shall prevail. The ISO/IEC Guide 2 is 
incorporated by reference with the approval of the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies are available from the International Organization for 
Standardization, 1, rue de Varembe, Case postale 56, CH-1211 Geneve 20, 
Switzerland, or on the Internet at ``http://www.iso.ch'' or may be 
examined at the Food and Drug Administration's Medical Library, 5600 
Fishers Lane, rm. 11B-40, Rockville, MD 20857, or the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.


Sec. 26.61  Purpose of this part.

     This part specifies the conditions by which each party will accept 
or recognize results of conformity assessment procedures, produced by 
the other party's conformity assessment bodies (CAB's) or authorities, 
in assessing conformity to the importing party's requirements, as 
specified on a sector-specific basis in subparts A and B of this part, 
and to provide for other related cooperative activities. The objective 
of such mutual recognition is to provide effective market access 
throughout the territories of the parties with regard to conformity 
assessment for all products covered under this part. If any obstacles 
to such access arise, consultations will promptly be held. In the 
absence of a satisfactory outcome of such consultations, the party 
alleging its market access has been denied, may, within 90 days of such 
consultation, invoke its right to terminate this part in accordance 
with Sec. 26.80.


Sec. 26.62  General obligations.

    (a) The United States shall, as specified in subparts A and B of 
this part, accept or recognize results of specified procedures, used in 
assessing conformity to specified legislative, regulatory, and 
administrative provisions of the United States, produced by the other 
party's conformity assessment bodies (CAB's) and/or authorities.
    (b) The European Community (EC) and its Member States shall, as 
specified in subparts A and B of this part, accept or recognize results 
of specified procedures, used in assessing conformity to specified 
legislative, regulatory, and administrative provisions of the EC and 
its Member States, produced by the other party's CAB's and/or 
authorities.
    (c) Where sectoral transition arrangements have been specified in 
subparts A and B of this part, the above obligations will apply 
following the successful completion of those sectoral transition 
arrangements, with the understanding that the conformity assessment 
procedures utilized assure conformity to the satisfaction of the 
receiving party, with applicable legislative, regulatory, and 
administrative provisions of that party, equivalent to the assurance 
offered by the receiving party's own procedures.


Sec. 26.63   General coverage of this part.

    (a) This part applies to conformity assessment procedures for 
products and/or processes and to other related cooperative activities 
as described in this part.
    (b) Subparts A and B of this part may include:
    (1) A description of the relevant legislative, regulatory, and 
administrative provisions pertaining to the conformity assessment 
procedures and technical regulations;
    (2) A statement on the product scope and coverage;
    (3) A list of designating authorities;
    (4) A list of agreed conformity assessment bodies (CAB's) or 
authorities or a source from which to obtain a list of such bodies or 
authorities and a statement of the scope of the conformity assessment 
procedures for which each has been agreed;
    (5) The procedures and criteria for designating the CAB's;

[[Page 17769]]

    (6) A description of the mutual recognition obligations;
    (7) A sectoral transition arrangement;
    (8) The identity of a sectoral contact point in each party's 
territory; and
    (9) A statement regarding the establishment of a Joint Sectoral 
Committee.
    (c) This part shall not be construed to entail mutual acceptance of 
standards or technical regulations of the parties and, unless otherwise 
specified in subpart A or B of this part, shall not entail the mutual 
recognition of the equivalence of standards or technical regulations.


Sec. 26.64   Transitional arrangements.

    The parties agree to implement the transitional commitments on 
confidence building as specified in subparts A and B of this part.
    (a) The parties agree that each sectoral transitional arrangement 
shall specify a time period for completion.
    (b) The parties may amend any transitional arrangement by mutual 
agreement.
    (c) Passage from the transitional phase to the operational phase 
shall proceed as specified in subparts A and B of this part, unless 
either party documents that the conditions provided in such subpart for 
a successful transition are not met.


Sec. 26.65   Designating authorities.

    The parties shall ensure that the designating authorities specified 
in subpart B of this part have the power and competence in their 
respective territories to carry out decisions under this part to 
designate, monitor, suspend, remove suspension of, or withdraw 
conformity assessment bodies (CAB's).


Sec. 26.66   Designation and listing procedures.

    The following procedures shall apply with regard to the designation 
of conformity assessment bodies (CAB's) and the inclusion of such 
bodies in the list of CAB's in subpart B of this part:
    (a) The designating authority identified in subpart B of this part 
shall designate CAB's in accordance with the procedures and criteria 
set forth in subpart B of this part;
    (b) A party proposing to add a CAB to the list of such bodies in 
subpart B of this part shall forward its proposal of one or more 
designated CAB's in writing to the other party with a view to a 
decision by the Joint Committee;
    (c) Within 60 days following receipt of the proposal, the other 
party shall indicate its position regarding either its confirmation or 
its opposition. Upon confirmation, the inclusion in subpart B of this 
part of the proposed CAB or CAB's shall take effect; and
    (d) In the event that the other party contests on the basis of 
documented evidence the technical competence or compliance of a 
proposed CAB, or indicates in writing that it requires an additional 30 
days to more fully verify such evidence, such CAB shall not be included 
on the list of CAB's in subpart B of this part. In this instance, the 
Joint Committee may decide that the body concerned be verified. After 
the completion of such verification, the proposal to list the CAB in 
subpart B may be resubmitted to the other party.


Sec. 26.67  Suspension of listed conformity assessment bodies.

    The following procedures shall apply with regard to the suspension 
of a conformity assessment body (CAB) listed in subpart B of this part.
    (a) A party shall notify the other party of its contestation of the 
technical competence or compliance of a CAB listed in subpart B of this 
part and the contesting party's intent to suspend such CAB. Such 
contestation shall be exercised when justified in an objective and 
reasoned manner in writing to the other party;
    (b) The CAB shall be given prompt notice by the other party and an 
opportunity to present information in order to refute the contestation 
or to correct the deficiencies which form the basis of the 
contestation;
    (c) Any such contestation shall be discussed between the parties in 
the Joint Sectoral Committee described in subpart B of this part. If 
there is no Joint Sectoral Committee, the contesting party shall refer 
the matter directly to the Joint Committee. If agreement to suspend is 
reached by the Joint Sectoral Committee or, if there is no Joint 
Sectoral Committee, by the Joint Committee, the CAB shall be suspended;
    (d) Where the Joint Sectoral Committee or Joint Committee decides 
that verification of technical competence or compliance is required, it 
shall normally be carried out in a timely manner by the party in whose 
territory the body in question is located, but may be carried out 
jointly by the parties in justified cases;
    (e) If the matter has not been resolved by the Joint Sectoral 
Committee within 10 days of the notice of contestation, the matter 
shall be referred to the Joint Committee for a decision. If there is no 
Joint Sectoral Committee, the matter shall be referred directly to the 
Joint Committee. If no decision is reached by the Joint Committee 
within 10 days of the referral to it, the CAB shall be suspended upon 
the request of the contesting party;
    (f) Upon the suspension of a CAB listed in subpart B of this part, 
a party is no longer obligated to accept or recognize the results of 
conformity assessment procedures performed by that CAB subsequent to 
suspension. A party shall continue to accept the results of conformity 
assessment procedures performed by that CAB prior to suspension, unless 
a regulatory authority of the party decides otherwise based on health, 
safety or environmental considerations or failure to satisfy other 
requirements within the scope of subpart B of this part; and
    (g) The suspension shall remain in effect until agreement has been 
reached by the parties upon the future status of that body.


Sec. 26.68   Withdrawal of listed conformity assessment bodies.

    The following procedures shall apply with regard to the withdrawal 
from subpart B of this part of a conformity assessment body (CAB):
    (a) A party proposing to withdraw a CAB listed in subpart B of this 
part shall forward its proposal in writing to the other party;
    (b) Such CAB shall be promptly notified by the other party and 
shall be provided a period of at least 30 days from receipt to provide 
information in order to refute or to correct the deficiencies which 
form the basis of the proposed withdrawal;
    (c) Within 60 days following receipt of the proposal, the other 
party shall indicate its position regarding either its confirmation or 
its opposition. Upon confirmation, the withdrawal from the list in 
subpart B of this part of the CAB shall take effect;
    (d) In the event the other party opposes the proposal to withdraw 
by supporting the technical competence and compliance of the CAB, the 
CAB shall not at that time be withdrawn from the list of CAB's in 
subpart B of this part. In this instance, the Joint Sectoral Committee 
or the Joint Committee may decide to carry out a joint verification of 
the body concerned. After the completion of such verification, the 
proposal for withdrawal of the CAB may be resubmitted to the other 
party; and
    (e) Subsequent to the withdrawal of a CAB listed in subpart B of 
this part, a party shall continue to accept the results of conformity 
assessment procedures performed by that CAB prior to withdrawal, unless 
a regulatory authority of the party decides otherwise based on health, 
safety, and environmental considerations or failure to satisfy other 
requirements within the scope of subpart B of this part.

[[Page 17770]]

Sec. 26.69   Monitoring of conformity assessment bodies.

    The following shall apply with regard to the monitoring of 
conformity assessment bodies (CAB's) listed in subpart B of this part:
    (a) Designating authorities shall assure that their CAB's listed in 
subpart B of this part are capable and remain capable of properly 
assessing conformity of products or processes, as applicable, and as 
covered in subpart B of this part. In this regard, designating 
authorities shall maintain, or cause to maintain, ongoing surveillance 
over their CAB's by means of regular audit or assessment;
    (b) The parties undertake to compare methods used to verify that 
the CAB's listed in subpart B of this part comply with the relevant 
requirements of subpart B of this part. Existing systems for the 
evaluation of CAB's may be used as part of such comparison procedures;
    (c) Designating authorities shall consult as necessary with their 
counterparts, to ensure the maintenance of confidence in conformity 
assessment procedures. With the consent of both parties, this 
consultation may include joint participation in audits/inspections 
related to conformity assessment activities or other assessments of 
CAB's listed in subpart B of this part; and
    (d) Designating authorities shall consult, as necessary, with the 
relevant regulatory authorities of the other party to ensure that all 
technical requirements are identified and are satisfactorily addressed.


Sec. 26.70   Conformity assessment bodies.

    Each party recognizes that the conformity assessment bodies (CAB's) 
listed in subpart B of this part fulfill the conditions of eligibility 
to assess conformity in relation to its requirements as specified in 
subpart B of this part. The parties shall specify the scope of the 
conformity assessment procedures for which such bodies are listed.


Sec. 26.71   Exchange of information.

    (a) The parties shall exchange information concerning the 
implementation of the legislative, regulatory, and administrative 
provisions identified in subparts A and B of this part.
    (b) Each party shall notify the other party of legislative, 
regulatory, and administrative changes related to the subject matter of 
this part at least 60 days before their entry into force. Where 
considerations of safety, health or environmental protection require 
more urgent action, a party shall notify the other party as soon as 
practicable.
    (c) Each party shall promptly notify the other party of any changes 
to its designating authorities and/or conformity assessment bodies 
(CAB's).
    (d) The parties shall exchange information concerning the 
procedures used to ensure that the listed CAB's under their 
responsibility comply with the legislative, regulatory, and 
administrative provisions outlined in subpart B of this part.
    (e) Regulatory authorities identified in subparts A and B of this 
part shall consult as necessary with their counterparts, to ensure the 
maintenance of confidence in conformity assessment procedures and to 
ensure that all technical requirements are identified and are 
satisfactorily addressed.


 Sec. 26.72   Sectoral contact points.

    Each party shall appoint and confirm in writing contact points to 
be responsible for activities under subparts A and B of this part.


Sec. 26.73   Joint Committee.

    (a) A Joint Committee consisting of representatives of the United 
States and the European Community (EC) will be established. The Joint 
Committee shall be responsible for the effective functioning of this 
part.
    (b) The Joint Committee may establish Joint Sectoral Committees 
comprised of appropriate regulatory authorities and others deemed 
necessary.
    (c) The United States and the EC shall have one vote in the Joint 
Committee. The Joint Committee shall make its decisions by unanimous 
consent. The Joint Committee shall determine its own rules and 
procedures.
    (d) The Joint Committee may consider any matter relating to the 
effective functioning of this part. In particular it shall be 
responsible for:
    (1) Listing, suspension, withdrawal and verification of conformity 
assessment bodies (CAB's) in accordance with this subpart and subpart B 
of this part;
    (2) Amending transitional arrangements in subparts A and B of this 
part;
    (3) Resolving any questions relating to the application of this 
part not otherwise resolved in the respective Joint Sectoral 
Committees;
    (4) Providing a forum for discussion of issues that may arise 
concerning the implementation of this part;
    (5) Considering ways to enhance the operation of this part;
    (6) Coordinating the negotiation of additional subparts; and
    (7) Considering whether to amend this part in accordance with 
Sec. 26.80.
    (e) When a party introduces new or additional conformity assessment 
procedures affecting subpart A or B of this part, the parties shall 
discuss the matter in the Joint Committee with a view to bringing such 
new or additional procedures within the scope of this part, where 
relevant.


 Sec. 26.74   Preservation of regulatory authority.

    (a) Nothing in this part shall be construed to limit the authority 
of a party to determine, through its legislative, regulatory, and 
administrative measures, the level of protection it considers 
appropriate for safety; for protection of human, animal, or plant life 
or health; for the environment; for consumers; and otherwise with 
regard to risks within the scope of the applicable subpart A or B of 
this part.
    (b) Nothing in this part shall be construed to limit the authority 
of a regulatory authority to take all appropriate and immediate 
measures whenever it ascertains that a product may:
    (1) Compromise the health or safety of persons in its territory;
    (2) Not meet the legislative, regulatory, or administrative 
provisions within the scope of the applicable subpart A or B of this 
part; or
    (3) Otherwise fail to satisfy a requirement within the scope of the 
applicable subpart A or B of this part. Such measures may include 
withdrawing the products from the market, prohibiting their placement 
on the market, restricting their free movement, initiating a product 
recall, and preventing the recurrence of such problems, including 
through a prohibition on imports. If the regulatory authority takes 
such action, it shall inform its counterpart authority and the other 
party within 15 days of taking such action, providing its reasons.


Sec. 26.75   Suspension of recognition obligations.

    Either party may suspend its obligations under subpart A or B of 
this part, in whole or in part, if:
    (a) A party suffers a loss of market access for the party's 
products within the scope of subpart A or B of this part as a result of 
the failure of the other party to fulfill its obligations under this 
part;
    (b) The adoption of new or additional conformity assessment 
requirements as referenced in Sec. 26.73(e) results in a loss of market 
access for the party's products within the scope of subpart B of this 
part because conformity assessment bodies (CAB's) designated by the 
party in order to meet such requirements have not been recognized by 
the party implementing the requirements; or

[[Page 17771]]

    (c) The other party fails to maintain legal and regulatory 
authorities capable of implementing the provisions of this part.


Sec. 26.76  Confidentiality.

    (a) Each party agrees to maintain, to the extent required under its 
laws, the confidentiality of information exchanged under this part.
    (b) In particular, neither party shall disclose to the public, nor 
permit a conformity assessment body (CAB) to disclose to the public, 
information exchanged under this part that constitutes trade secrets, 
confidential commercial or financial information, or information that 
relates to an ongoing investigation.
    (c) A party or a CAB may, upon exchanging information with the 
other party or with a CAB of the other party, designate the portions of 
the information that it considers to be exempt from disclosure.
    (d) Each party shall take all precautions reasonably necessary to 
protect information exchanged under this part from unauthorized 
disclosure.


 Sec. 26.77   Fees.

    Each party shall endeavor to ensure that fees imposed for services 
under this part shall be commensurate with the services provided. Each 
party shall ensure that, for the sectors and conformity assessment 
procedures covered under this part, it shall charge no fees with 
respect to conformity assessment services provided by the other party.


 Sec. 26.78   Agreements with other countries.

    Except where there is written agreement between the parties, 
obligations contained in mutual recognition agreements concluded by 
either party with a party not a party to this part (a third party) 
shall have no force and effect with regard to the other party in terms 
of acceptance of the results of conformity assessment procedures in the 
third party.


Sec. 26.79   Territorial application.

    This part shall apply, on the one hand, to the territories in which 
the Treaty establishing the European Community (EC) is applied, and 
under the conditions laid down in that Treaty and, on the other hand, 
to the territory of the United States.


Sec. 26.80  Entry into force, amendment and termination.

    (a) The ``Agreement on Mutual Recognition Between the United States 
of America and the European Community,'' from which this part is 
derived, including its sectoral annexes on telecommunications 
equipment, electromagnetic compatibility, electrical safety, 
recreational craft, pharmaceutical GMP inspections, and medical devices 
shall enter into force on the first day of the second month following 
the date on which the parties have exchanged letters confirming the 
completion of their respective procedures for the entry into force of 
that agreement.
    (b) That agreement including any sectoral annex may, through the 
Joint Committee, be amended in writing by the parties to that 
agreement. Those parties may add a sectoral annex upon the exchange of 
letters. Such annex shall enter into force 30 days following the date 
on which those parties have exchanged letters confirming the completion 
of their respective procedures for the entry into force of the sectoral 
annex.
    (c) Either party to that agreement may terminate that agreement in 
its entirety or any individual sectoral annex thereof by giving the 
other party to that agreement 6 months notice in writing. In the case 
of termination of one or more sectoral annexes, the parties to that 
agreement will seek to achieve by consensus to amend that agreement, 
with a view to preserving the remaining Sectoral Annexes, in accordance 
with the procedures in this section. Failing such consensus, that 
agreement shall terminate at the end of 6 months.
    (d) Following termination of that agreement in its entirety or any 
individual sectoral annex thereof, a party to that agreement shall 
continue to accept the results of conformity assessment procedures 
performed by conformity assessment bodies under that agreement prior to 
termination, unless a regulatory authority in the party decides 
otherwise based on health, safety and environmental considerations or 
failure to satisfy other requirements within the scope of the 
applicable sectoral annex.


Sec. 26.81  Final provisions.

    (a) The sectoral annexes referred to in Sec. 26.80(a), as well as 
any new sectoral annexes added pursuant to Sec. 26.80(b), shall form an 
integral part of the ``Agreement on Mutual Recognition Between the 
United States of America and the European Community,'' from which this 
part is derived.
    (b) For a given product or sector, the provisions contained in 
subparts A and B of this part shall apply in the first place, and the 
provisions of subpart C of this part in addition to those provisions. 
In the case of any inconsistency between the provisions of subpart A or 
B of this part and subpart C of this part, subpart A or B shall 
prevail, to the extent of that inconsistency.
    (c) The agreement from which this part is derived shall not affect 
the rights and obligations of the parties under any other international 
agreement.
    (d) In the case of subpart B of this part, the parties shall review 
the status of such subpart at the end of 3 years from entry into force 
of subpart B.

    Dated: April 6, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-9486 Filed 4-9-98; 8:45 am]
BILLING CODE 4160-01-F