[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Notices]
[Pages 14789-14797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8149]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0025]


Medical Devices; Third-Party Review of Selected Premarket 
Notifications; Pilot Program

AGENCY: Food and Drug Administration, HHS.

Action: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
voluntary pilot program to test the feasibility of using third-party 
reviews to improve the efficiency of the agency's review of premarket 
notifications for medical devices. To implement the pilot program, FDA 
is announcing simplified agency procedures and practices to process 
premarket notifications (510(k)'s) submitted by, and with a review 
prepared by, third-party review organizations (third parties). In its 
discretion, FDA will select third parties pursuant to the general 
statements of policy with respect to competence and freedom from 
conflicts of interest announced in this document. FDA recognizes that 
it has long been common practice for some firms to engage third parties 
to make a preliminary review and assist in the quality control of 
documents prior to their submission in 510(k)'s. FDA believes a similar 
third-party effort may be useful to improve the efficiency of the 
agency's review process. The pilot program will allow FDA to evaluate 
the feasibility of using the results of a third party's review in lieu 
of the agency's initial review effort. This action is part of efforts 
in pursuit of the reinventing Government goals of the National 
Performance Review.
DATES: The pilot program will begin August 1, 1996, and will run for a 
2-year period. FDA will apply the pilot program procedures to 510(k)'s 
received during this period from recognized third parties. FDA is now 
accepting applications for recognition of prospective third parties and 
will continue to do so through June 3, 1996. To help prospective third 
parties prepare these applications, FDA will hold an information 
session for prospective third parties on April 15, 1996, to review the 
third-party recognition process and criteria described in this notice, 
and to answer related questions.
    Submit written comments on the pilot program by June 3, 1996.
    Submit written comments on the information collection requirements 
by June 3, 1996. At FDA's request, the Office of Management and Budget 
(OMB) authorized emergency processing of this information collection. 
OMB approved the information collection for 90 days, under OMB control 
no. 0910-0318.

ADDRESSES: Prospective third parties should submit an application for 
recognition, in duplicate, to the Division of Small Manufacturers 
Assistance (HFZ-220), ATTN: Third-Party Recognition, Center for Devices 
and Radiological Health, Food and Drug Administration, 1350 Piccard 
Dr., Rockville, MD 20850, 1-800-638-2041 or 301-443-7491, both at ext. 
105, or FAX 301-443-8818. 510(k)'s reviewed by third parties should be 
submitted to the Document Mail Center (HFZ-401), ATTN: Third-Party 
Review, Center for Devices and Radiological Health, Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850.
    Written comments regarding the pilot program and the information 
collection requirements may be submitted to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857. Comments should be identified with the 
docket number found in brackets in the heading of this document.
    Persons interested in attending the information session for 
prospective third parties should obtain registration information as 
soon as possible. Copies of a facsimile containing this

[[Page 14790]]
information are available from the Center for Devices and Radiological 
Health's (CDRH's) Facts on Demand system by dialing 1-800-899-0381 or 
1-301-827-0111 and requesting document number 258. Internet users can 
obtain registration information by using the World Wide Web; FDA's home 
page address may be accessed at http://www.fda.gov and then select the 
Medical Devices and Radiological Health option. Then select the Topic 
Index option and then scroll down to the Third Party Review option. 
Registration information is also available from the electronic docket 
administered by the Division of Small Manufacturers Assistance and is 
available to anyone with a video terminal or personal computer with a 
modem (1-800-252-1366 or 1-301-594-2741) by making the following menu 
choices: 2-Medical Devices Regulations; 8-Third Party Review FR Notice. 
FDA encourages interested third parties to consider attending this 
session. FDA will make an initial list of recognized third parties 
publicly available before commencement of the pilot program, and will 
update the list as changes occur.

    A package of information explaining the Third Party Review Program 
will be distributed at the information sesssion on April 15, 1996. If 
you are unable to attend the information session and would like the 
Third Party Review Program information package, please call 1-800-638-
2041 or 301-443-7491, both at ext. 105, or FAX 301-443-8818 with your 
name and mailing address, and the package will be mailed after April 
15, 1996.
FOR FURTHER INFORMATION CONTACT: Eric J. Rechen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION:

I. Background

A. Purpose of Section 510(k)

    The current regulatory framework for medical devices was created by 
the Medical Device Amendments of 1976 (the amendments) to the Federal 
Food, Drug, and Cosmetic Act (the act), as modified by the Safe Medical 
Devices Act of 1990 and the Medical Device Amendments of 1992. The 
amendments established in section 513(a) of the act (21 U.S.C. 360c(a)) 
three device classes and directed FDA to publish regulations 
classifying each device on the market as of the amendments' enactment. 
Classification is based on the level of control necessary to provide 
reasonable assurance of the safety and effectiveness of a device. Class 
I devices are subject only to general controls, including manufacturer 
registration, device listing, 510(k), records and reports, and current 
good manufacturing practice requirements. FDA may, by regulation, 
exempt a class I device from certain of these requirements, including 
510(k) requirements. Class II devices are subject to special controls 
in addition to general controls, such as promulgation of performance 
standards, postmarket surveillance, patient registries, and 
dissemination of guidelines and recommendations. Class III devices are 
subject to premarket approval and general controls. A preamendments 
class III device is not required to undergo premarket approval until 
the effective date of a regulation calling for premarket approval under 
section 515 of the act (21 U.S.C. 360e).
    Section 513(f) of the act contains special classification 
provisions for postamendments devices. A device introduced on or after 
the amendments' enactment date (May 28, 1976) is automatically in class 
III and must receive premarket approval or be reclassified before 
marketing unless it is substantially equivalent to a predicate device 
(a device marketed before the amendments' enactment, or a device 
introduced after the amendments' enactment that FDA has reclassified 
from class III into class I or II).
    Section 510(k) of the act provides a means to ensure that 
manufacturers do not intentionally or unintentionally circumvent the 
automatic classification provisions of Sec. 513(f). Under Sec. 510(k), 
a person who intends to begin introduction of a device into commercial 
distribution is required to report to FDA by submitting a 510(k) at 
least 90 days in advance. FDA reviews 510(k)'s to determine if a new 
device is substantially equivalent to a predicate device. For purposes 
of determining substantial equivalence, a new device may also be 
compared to a device that FDA has found to be substantially equivalent 
through the 510(k) process. A device determined by FDA to be 
substantially equivalent is in the same class and may be introduced to 
the market subject to the same regulatory controls as the device to 
which it is substantially equivalent. Before marketing the device, the 
manufacturer must receive an order, in the form of a letter, by which 
FDA finds the device to be substantially equivalent. A device 
determined to be not substantially equivalent is automatically in class 
III and must receive premarket approval or be reclassified before it is 
marketed.
    The meaning of the term ``substantially equivalent'' is discussed 
in section 513(i) of the act. Substantial equivalence means, in 
essence, that a device: (1) Has the same intended use and the same 
technological characteristics as a predicate device; or (2) has the 
same intended use and different technological characteristics, but 
there is information in the 510(k) demonstrating that the device is as 
safe and effective as a legally marketed device and the device does not 
raise different questions of safety and effectiveness than the 
predicate device. Substantial equivalence determinations are currently 
made by scientific review staff within CDRH based primarily upon 
information provided by a manufacturer's 510(k). FDA has published 
regulations (part 807 (21 CFR part 807, subpart E)) specifying 510(k) 
content and procedures. FDA has also developed numerous guidance 
documents and policy memoranda for the 510(k) program that are 
available from CDRH's DSMA, as discussed later in this notice.
    Since the inception of the 510(k) program in 1976, FDA has received 
more than 90,000 510(k)'s, approximately 6,000 of which were received 
in fiscal year (FY) 1995. Approximately 80 percent of 510(k)'s have 
resulted in substantially equivalent determinations, 2 percent in not 
substantially equivalent determinations, and the remainder in 
administrative actions such as withdrawal by the submitter or deletion 
by FDA due to lack of response by a submitter. During the second half 
of FY 1995, approximately 20 percent of substantially equivalent 
determinations were for class I devices, 76 percent were for class II 
devices, and 4 percent were for class III devices.

B. Initial Announcement of the Pilot Program

    On April 6, 1995, FDA announced its intent to conduct a limited 
pilot program of third-party review of selected 510(k)'s (hereinafter 
referred to as the April announcement). This initiative is one aspect 
of FDA's efforts in pursuit of the reinventing Government goals of the 
National Performance Review. The purpose of the pilot program is to 
test the feasibility of third-party review of selected 510(k)'s, as an 
alternative to FDA's primary review.
    In the Federal Register of June 1, 1995 (60 FR 28618), FDA 
published a notice providing an outline of the proposed pilot program 
(hereinafter referred to as the June 1 notice) and announcing a June 
19, 1995, public workshop to

[[Page 14791]]
discuss the proposal. The June 1 notice and the April announcement 
described key elements of the proposed pilot program:
     FDA will designate the types of devices eligible for 
third-party review. The devices will be in class I or II, involve low- 
to moderate-risk, and have a clear basis for review. The pilot program 
will exclude 510(k)'s requiring clinical data for a decision.
     Third parties will be individually accepted by FDA. FDA 
will outline criteria covering personnel qualifications and controls 
over potential conflicts of interest.
     Industry participation will be voluntary. A manufacturer 
that chooses to participate will submit its 510(k) directly to a 
recognized third party; the third party may assess a fee for its 
services. Manufacturers that do not wish to participate may continue to 
submit 510(k)'s to FDA.
     The selected third party will conduct a complete review of 
the 510(k), document the review, and make a recommendation to FDA. FDA 
will check the review, make a substantial equivalence decision, and 
issue a decision letter.
     The pilot program will begin in FY 1996 and will operate 
for 2 years. FDA will evaluate it during the second year to determine 
whether it should be continued as is, modified, or terminated.
    The June 19 public workshop provided a forum to discuss FDA's 
proposed approach to implementing third-party review of selected 
510(k)'s and a means of obtaining public comments and suggestions that 
would help FDA refine its plans for the pilot program. Topics discussed 
at the workshop included: The role of third parties; types of devices 
eligible for third-party review; safeguards necessary to ensure the 
quality and integrity of the pilot program; and funding of third-party 
reviews. More than 200 persons attended the workshop, including 
representatives of the device industry, potential third parties, 
consumers, and health professionals. In addition to presentations and 
comments at the workshop, FDA accepted written comments through July 7, 
1995.
    In general, these presentations and comments showed broad support 
for a pilot program. Some industry representatives expressed concern, 
however, about limitations on the pilot program that may restrict 
manufacturers' incentive to participate. In particular, they commented 
that including only low- to moderate-risk devices in the pilot program 
and limiting third parties' role to making recommendations rather than 
final decisions might result in marketing clearance decisions that are 
no faster, and perhaps slower, than those made by FDA alone. In 
addition, some industry representatives advocated: Standards-based 
third-party reviews rather than reviews focused on substantial 
equivalence; increased harmonization with international standards; and 
reliance on existing accreditation systems and criteria for potential 
third parties. Only a few manufacturers expressed opposition to the 
pilot program, arguing that it would divert FDA's resources away from 
other reviews or result in inconsistent marketing clearance decisions.
    Potential third parties expressed strong interest in the pilot 
program and indicated that they have the capability, independence, and 
controls to conduct sound and unbiased reviews. Most advocated that FDA 
rely on existing accreditation systems and criteria for potential third 
parties, and that the setting of fees should be left to market forces.
    Consumer and professional representatives recommended that FDA 
proceed cautiously with the pilot program. They expressed concern that 
third-party review could result in some loss of public accountability 
and that effective controls are needed to ensure technically-competent 
reviews free of any conflict of interest that could undermine the 
objectivity of the review process.
    In the months following the June 19 workshop, FDA has considered 
all comments provided at the workshop and in response to the June 1 
notice. FDA has attempted to incorporate suggestions to the extent that 
they are consistent with existing statutory requirements and the pilot 
program's purpose and timeframe. For example, while FDA continues to 
believe that the pilot program should be limited to low- to moderate-
risk devices, FDA is significantly expanding the number of devices 
(particularly in vitro diagnostics) eligible for third-party review and 
is accepting the suggestion that there be a 30-day performance goal for 
FDA's decisionmaking based on third-party reviews. Given that FDA's 
cumulative review time is currently averaging approximately 90 days for 
510(k) decisions involving class I devices (and is higher for other 
510(k) decisions), a 30-day performance goal for FDA decisions under 
the pilot program in conjunction with a timely third-party review 
should provide a tangible incentive for manufacturers to participate in 
the pilot program.
    Similarly, while FDA is unaware of any existing accreditation 
program for potential third parties that is directly suited to 510(k) 
review--and is therefore unable to incorporate reliance on such an 
accreditation for purposes of this pilot program--FDA is establishing a 
streamlined process for third parties to seek participation in the 
pilot program. This process should not present an undue burden to 
qualified third parties that are ready to conduct reviews. However, FDA 
will only recognize third parties that establish stringent criteria 
regarding potential conflicts of interest. Having third parties who 
establish such criteria--in conjunction with FDA's oversight of all 
third-party reviews and potential for more indepth auditing--should 
ensure the quality and integrity of 510(k) decisions made under the 
pilot program.
    FDA is not adopting the suggestion that it establish a specific 
performance goal for the timeliness of reviews by third parties. FDA 
believes such a goal is unnecessary because timeliness of third-party 
reviews is likely to be a contractual matter between manufacturers and 
third parties. In addition, market forces will provide an incentive for 
third parties to perform timely reviews, i.e., timeliness will be an 
important consideration when a manufacturer decides whether to submit a 
510(k) to a particular third party or to FDA.
    FDA has received suggestions that third parties be given final 
decisionmaking authority under the pilot program and that third parties 
conduct 510(k) reviews that are focused on criteria other than 
substantial equivalence. FDA is not adopting these suggestions in the 
pilot program. It is beyond the scope of the pilot program to test an 
approach that is completely harmonized with other regulatory systems, 
such as the third-party system of the European Union. The pilot program 
does contain key elements of the European model, however, and will 
provide information useful in assessing its potential applicability in 
this country. FDA remains committed to the goal of global harmonization 
and will continue to work with its regulatory counterparts toward that 
end.
    FDA welcomes further comments concerning the pilot program. FDA 
will use comments to make necessary adjustments during implementation 
of the pilot program and to conduct an evaluation.

[[Page 14792]]


II. Outline of the Third-Party Review Pilot Program

A. Purpose

    The overall purpose of the pilot program is to determine whether it 
is feasible for third parties in the private sector to conduct selected 
510(k) reviews that, until now, have been conducted by FDA. This 
includes determining:
     The willingness of qualified third parties to participate;
     The willingness of manufacturers to submit 510(k)'s to a 
third party;
     The quality, timeliness, and independence of third-party 
reviews; and
     Any discernable impacts on FDA resource needs, review 
times, and decisions, and on the total time needed for manufacturers to 
obtain 510(k) decisions.
    If the pilot approach proves successful, it will: (1) Enable FDA to 
target its scientific review resources at higher-risk devices while 
maintaining a high degree of confidence in the review by third parties 
of low- to moderate-risk devices; and (2) provide manufacturers of 
eligible devices an alternative review process that can yield more 
rapid 510(k) decisions. FDA intends the pilot program to test the 
feasibility of attaining these outcomes.
    The pilot program includes safeguards to maintain a high level of 
quality in the review of 510(k)'s submitted to third parties.
    Participation in the pilot is entirely voluntary. Manufacturers may 
continue to submit 510(k)'s directly to FDA. Manufacturers may also 
employ the assistance of third parties other than those recognized by 
FDA, but only 510(k)'s reviewed by recognized third parties will be 
eligible for the pilot program's simplified processing procedures.
    Although the guidance set forth in this notice does not create or 
confer any rights on any person, and does not operate to bind FDA in 
any way, it does represent the agency's current thinking on third-party 
review of 510(k)'s.

B. Devices Eligible for Third-Party Review

    During the pilot program, 510(k)'s for the following two categories 
of devices will be eligible for review by third parties, except when a 
determination of substantial equivalence necessitates review of 
clinical data:
     All class I devices that are not exempt from 510(k); and
     Class II devices designated by FDA for inclusion in the 
pilot program, for which FDA has made device-specific review guidance 
available.
    There are more than 200 types of devices classified by FDA in class 
I that have not been exempted from 510(k), many of which are in vitro 
diagnostic devices. FDA is making available a list of these devices 
(see section III of this document for information on obtaining a copy). 
FDA currently receives approximately 1,100 510(k)'s per year for these 
devices.
    FDA is also making available a preliminary list of class II devices 
that it intends to include in the pilot program (see section III of 
this document for information on obtaining a copy of the list or any 
associated review guidance). Prior to commencement of the pilot 
program, and on a quarterly basis during the program's first year, FDA 
will make review guidance available for a portion of the devices on the 
list and will update the list to designate those devices as being 
eligible for third-party review. FDA intends all of the class II 
devices on the preliminary list to be eligible for third-party review 
by the end of the first year of the pilot program, but this may be 
affected by factors such as workload or resource changes in CDRH's 
Office of Device Evaluation and the extent or nature of public comments 
received in the development of guidance documents.
    Any 510(k) for which clinical data are needed to make a 
determination of substantial equivalence will continue to be subject to 
primary review by FDA and will not be processed by FDA under the 
special procedures for this pilot program. 510(k)'s for the above two 
categories of devices normally do not contain clinical data and will 
typically be candidates for inclusion in the pilot program. The need 
for clinical data is, however, a matter of expert judgment and is often 
dependent on the nature of any differences (e.g., new indications for 
use) between the new device and the device to which it is being 
compared. Manufacturers and third parties seeking guidance on the need 
for clinical data in a 510(k) should consult FDA's guidance documents 
and may also contact the appropriate review division in CDRH's Office 
of Device Evaluation.

C. Recognition of Third Parties

    FDA will recognize those third parties whose reviews of 510(k)'s it 
will consider during the pilot program. While the number of third 
parties to be recognized by FDA will necessarily be dependent on the 
number of qualified applicants and the extent of their review 
capabilities, FDA believes that participation by 3 to 10 recognized 
third parties would be sufficient for purposes of the pilot program and 
would keep the pilot program within manageable limits. When selecting 
third parties for recognition, FDA will give foremost consideration to 
those third parties with the most qualified personnel and the most 
stringent conflict of interest standards that are capable of reviewing 
a broad range of device types or that are uniquely capable of reviewing 
specific types of devices. FDA will consider recognition requests from 
both domestic and foreign third parties.
    CDRH will maintain a list of third parties eligible to submit 
510(k) reviews to FDA. This list will provide the name, contact person, 
address, telephone number, and specialty (if any) of organizations that 
FDA has recognized for participation as third parties in the pilot 
program.
    FDA is announcing that it intends to hold an information session 
for prospective third parties on April 15, 1996, in Rockville, MD, to 
review the third-party recognition process and criteria described in 
this notice, and to answer related questions. FDA encourages interested 
third parties to consider attending this session before submitting a 
request for recognition. Persons interested in attending should obtain 
registration information as soon as possible. Copies of a facsimile 
containing this information are available from CDRH's Facts on Demand 
system by dialing 1-800-899-0381 or 1-301-827-0111 and requesting 
document number 258. Internet users can obtain registration information 
by using the World Wide Web; FDA's home page address may be accessed at 
http://www.fda.gov and then select the Medical Devices and Radiological 
Health option. Then select the Topic Index option and then scroll down 
to the Third Party Review option. Registration information is also 
available from the electronic docket administered by the Division of 
Small Manufacturers Assistance and is available to anyone with a video 
terminal or personal computer with a modem (1-800-252-1366 or 1-301-
594-2741) by making the following menu choices: 2-Medical Device 
Regulations; 8-Third Party Review FR Notice.
    Qualified organizations that wish to become a recognized third 
party for the pilot program should submit the following materials, in 
duplicate, no later than June 3, 1996:
    1. Information identifying the third party, including its name, 
contact person, address, telephone number, and fax number. A third 
party located outside the United States should also

[[Page 14793]]
identify the name, address, telephone number, and fax number of an 
authorized representative located within the United States who will 
serve as the third party's official correspondent with FDA.
    2. Identification of the devices the third party seeks to review. 
If a third party seeks to review only a subset of the devices eligible 
for third-party review under this pilot program, the devices should be 
clearly identified, such as by classification panel (i.e., all eligible 
devices within the panel) or by specific classification name and Code 
of Federal Regulations citation.
    3. Documentation that the third party meets its established 
criteria, as described in section II.D.1. and II.D.2. of this document, 
with respect to personnel qualifications and facilities.
    4. A copy of the written policies and procedures established by the 
third party to ensure that it and its employees involved in the third-
party review of 510(k)'s are free from conflicts of interest, as 
outlined in section II.D.3. of this document, and certification that 
the third party and its employees meet its established criteria.
    5. A statement that the third party consents to FDA inspection and 
copying of all records, correspondence, and other materials relating to 
any review conducted by the third party under this pilot program, 
including records on personnel education, training, skills, and 
experience, all documentation on prevention of conflicts of interest, 
and the third party's fee schedule and invoices for conducting 510(k) 
reviews.
    6. A statement that the third party will strictly preserve and 
protect the confidentiality of all information provided by any 
manufacturer and by FDA.
    When these materials are received by DSMA, a date-stamped 
acknowledgment letter will be faxed to the third party's official 
correspondent. DSMA will coordinate CDRH's review of these materials 
and respond to the third party within 30 days of the completion of the 
time period for submitting such materials with one of the following: A 
letter of recognition, a denial of recognition, or a request for 
additional information. CDRH may deny a request for recognition for any 
reason, including if it determines that the third party's personnel 
qualifications or criteria for ensuring conflicts of interest are 
inadequate, or if the third-party's submission does not place it among 
the most highly qualified candidates. CDRH may deem incomplete and 
delete a request for recognition if a third party fails to respond to a 
request for additional information within 10 days. Third parties may 
make a written request to the Director, Office of Health and Industry 
Programs, CDRH for reconsideration of a decision to deny or delete a 
request for recognition.
    A list of recognized third parties will be made available to the 
public through CDRH's Facts-on-Demand facsimile system (1-800-899-0381, 
document number 967), or the electronic docket (1-800-252-1366) (see 
section III. of this document for information on obtaining a copy) 
before commencement of the pilot program. The list will be updated as 
necessary and will be made available for the duration of the pilot 
program.
    Unless the third party requests that it be removed from FDA's 
recognition list, or FDA finds for any reason in its sole discretion--
including that the third party has not followed recognized rules of 
ethics or conduct, is not in fact independent, or has knowingly made 
any material misstatement of fact or circumstances or material 
misrepresentations of any kind--that the third party is no longer 
qualified, recognition will continue for the duration of the pilot 
program. If changes occur that significantly affect any information or 
certification provided to FDA, it is the responsibility of the third 
party to provide FDA with updated information and, if necessary, an 
updated certification, at the earliest possible opportunity.
    If FDA has reason to believe that a recognized third party no 
longer meets the criteria for participation in the pilot program, an 
opportunity for a meeting with the Director, Office of Health and 
Industry Programs, CDRH, will be provided prior to any decision 
concerning removal of the third party from FDA's list of recognized 
third parties.
    Consistent with current practice, FDA will accept 510(k)'s from 
third parties that have not been recognized, but FDA will give no 
weight to any review or recommendation provided by the nonrecognized 
third party and will treat the submission in the same manner as a 
510(k) submitted by a consultant.

D. Criteria for Third Parties

    To be recognized by FDA, a third party should demonstrate that it 
has the appropriate qualifications and facilities to conduct competent 
510(k) reviews, and has instituted effective controls to prevent any 
conflict of interest or appearance of conflict of interest that might 
affect the review process.
1. Personnel Qualifications
    FDA expects to recognize third parties that have sufficient 
personnel, with the necessary education, training, skills, and 
experience, to evaluate a substantial number of 510(k)'s in those 
categories of devices it accepts for review. FDA will consider several 
factors with respect to personnel qualifications when it considers who 
to recognize as third parties. These include:
    (a) Whether the third party has established, documented, and 
executed policies and procedures to ensure that 510(k)'s are reviewed 
by qualified personnel, and whether it will maintain records on the 
relevant education, training, skills, and experience of all personnel 
who contribute to the technical review of a 510(k);
    (b) Whether the third party has made available to its personnel 
clear, written instructions for their duties and responsibilities with 
respect to 510(k) reviews;
    (c) Whether the third party employs personnel who, as a whole, are 
qualified in all of the scientific disciplines addressed by the 
510(k)'s that the third party accepts for review;
    (d) Whether the third party has identified at least one individual 
who is responsible for providing supervision over 510(k) reviews and 
who has sufficient authority and competence to assess the quality and 
acceptability of these reviews; and
    (e) Whether the third party is prepared to conduct technically 
competent reviews at the time of requesting recognition by FDA.
    FDA is making available information on the general education and 
experience FDA requires of its scientific review personnel (see section 
III. of this document for information on obtaining a copy). Within 
CDRH's Office of Device Evaluation, the GS-12 level (as described in 
the information being made available) is usually considered to be the 
typical level at which reviewers assume full responsibility for 
conducting 510(k) reviews. A third party may adopt these criteria as 
one means of ensuring that its personnel having primary responsibility 
for review of a 510(k) for a class I device have appropriate education 
and experience. A third party may develop and apply alternative 
criteria that result in personnel having education and experience 
necessary and appropriate to review 510(k)'s for class I devices.
    For appropriate review of a particular class II device, FDA will 
expect specialized education or experience consistent with assuring a 
technically competent review.
2. Facilities
    FDA expects to recognize third parties that have the capability to 
interface with

[[Page 14794]]
FDA electronic data systems. At a minimum, this would include a 
computer system with a modem and an independent facsimile machine.
3. Prevention of Conflicts of Interest
    FDA expects to recognize third parties that will be impartial and 
free from any commercial, financial, and other pressures that might 
present a conflict of interest or an appearance of conflict of 
interest. To that end, when deciding whether to recognize a third 
party, FDA will consider whether the third party has established, 
documented, and executed policies and procedures to prevent any 
individual or organizational conflict of interest. Although it is not 
feasible to identify or state categorically or inflexibly all of the 
criteria for judging that a third party is free of conflicts of 
interest, the most common conditions that would indicate a potential 
conflict of interest are:
    (a) The third party is owned, operated, or controlled by a device 
manufacturer or distributor;
    (b) The third party or any of its personnel involved in 510(k) 
reviews has any ownership or other financial interest in any medical 
device, device manufacturer, or distributor;
    (c) The third party or any of its personnel involved in 510(k) 
reviews participates in the design, manufacture, or distribution of any 
medical device;
    (d) The third party or any of its personnel involved in 510(k) 
reviews provides consultative services to any device manufacturer or 
distributor regarding any specific devices;
    (e) The third party or any of its personnel involved in 510(k) 
reviews participates in the preparation of any 510(k); or
    (f) The fee charged or accepted by the third party is contingent or 
based upon the type of recommendation made by the third party.
    Nevertheless, a third party may: Assess a fee for its services; 
conduct other activities, such as objective testing or inspection of 
devices, if they do not affect the impartiality of 510(k) reviews; and 
provide information on 510(k) requirements to improve the organization 
or content of a 510(k) that it is reviewing.
    Where a third party uses the services of a contractor for 510(k) 
reviews, the third party is responsible for the contracted work of its 
contractor. The third party is to assure that the contractor meets the 
third party's established criteria for freedom from conflicts of 
interest.
    FDA is making available information on the conflict of interest 
standards it applies to its own review personnel (see section III. of 
this document for information on obtaining a copy). A third party may 
adopt these standards as one means of safeguarding its operations 
against conflicts of interest.
    FDA has considered additional mechanisms to ensure the independence 
of recognized third parties and to prevent even the appearance of forum 
shopping by manufacturers. One mechanism considered would be for 
manufacturers to submit their 510(k)'s first to FDA and then have the 
agency assign submissions to recognized third parties that are 
qualified to review them, much like FDA now assigns submissions to 
internal staff reviewers. Under this mechanism, manufacturers would 
then negotiate a fee with the third party and pay the fee directly. 
Although this mechanism would likely be effective in guarding against 
forum shopping, it has the major disadvantage, for purposes of the 
pilot program, of necessitating that FDA establish a special processing 
and assignment system for what could be a relatively large number of 
510(k)'s submitted in the short period of the pilot program. It also 
would restrict manufacturers' ability to negotiate fees, and limit 
other potentially beneficial competitive influences on the pilot 
program.
    Accordingly, for purposes of this pilot program, manufacturers are 
to contact recognized third parties directly to request review of their 
510(k)'s. FDA may refuse, however, to provide expedited processing of a 
manufacturer's 510(k)'s and consideration of the accompanying third-
party reviews if it appears to FDA, in its sole discretion, that the 
manufacturer has engaged in forum shopping. Although it is not feasible 
to identify or state categorically all of the criteria for evaluating 
whether a manufacturer has forum shopped, three factors that would 
indicate forum shopping are:
     A manufacturer has obtained reviews of the same 510(k) 
from more than one third party, or from a third party and directly from 
FDA;
     A manufacturer has contracted for a substantial number of 
third-party reviews (ordinarily more than 10 in 1 year) from the same 
third party when other recognized third parties have the necessary 
expertise and capacity to perform additional 510(k) reviews; or
     A manufacturer has contracted for reviews from the same 
third party the sum of fees for which is substantial (ordinarily 
exceeding $50,000 in 1 year) when other recognized third parties have 
the necessary expertise and capacity to perform additional 510(k) 
reviews.
    If one (or more) of these factors is present, there will be a 
presumption of forum shopping and FDA may refuse to provide expedited 
processing of a manufacturer's 510(k)'s unless the manufacturer can 
explain why the circumstances do not indicate forum shopping. 
Manufacturers' avoidance of the last two factors will have the added 
benefit of enhancing manufacturers' ability to contribute to the 
evaluation of the pilot program, i.e., manufacturers that contract with 
more than one third party during the course of the pilot program will 
have a better basis for assessing how each performs.

E. Purpose and Nature of a Third-Party Review

    The purpose of a third-party review is to evaluate a manufacturer's 
510(k), document the review, and make a recommendation to FDA 
concerning the substantial equivalence of the device. FDA will provide 
information on procedures and criteria that it uses for 510(k) reviews 
in general guidance and in a training program to be made available by 
FDA before commencement of the pilot program (see section III. of this 
document for information on obtaining a copy of FDA's general review 
guidance). Until then, interested persons may consult existing guidance 
such as HHS Publication FDA 95-4158 ``Premarket Notification 510(k)--
Regulatory Requirements for Medical Devices'' (August 1995). This 
publication provides an overview of device regulations, information on 
510(k), FDA requirements concerning 510(k) content and format, a 
description of the 510(k) review process, copies of particularly 
important policy memoranda, and additional information useful to 
manufacturers and third parties. A copy of this publication may be 
obtained by contacting CDRH's DSMA (see section III. of this document 
for additional information on obtaining a copy).
    FDA encourages third parties to be familiar with the requirements 
outlined in this publication and in subsequent guidance. The general 
guidance, as well as any device-specific review guidance made available 
by FDA, will assist the third party in producing reviews that are 
acceptable to FDA and that FDA can process in a timely manner.

F. Training for Recognized Third Parties

    FDA is currently planning to hold one or more training sessions for 
recognized third parties. (This training is in addition to the 
prerecognition information session discussed earlier in

[[Page 14795]]
this notice.) Recognized third parties are to complete this training 
before conducting 510(k) reviews under the pilot program. The primary 
emphasis of this training will be on how to conduct an appropriate 
review of a 510(k). Depending on demand, one or more sessions may focus 
on specific types of devices, such as in vitro diagnostic devices. FDA 
will provide additional information on this training when it sends 
letters of recognition to third parties participating in the pilot 
program.

G. Review Materials to be Submitted to FDA by a Third Party

    Upon completion of its review of a 510(k), a third party should 
submit the following documentation to FDA, in duplicate:
    1. A cover letter signed by the third party's official 
correspondent clearly identifying: the purpose of the submission; the 
name and address of the third party; the name and address of the 
manufacturer; the name of the device (trade name, common or usual name, 
and FDA classification name); the third party's recommendation with 
respect to the substantial equivalence of the device; and the date the 
third party first received the 510(k) from the manufacturer.
    2. A letter signed by the manufacturer authorizing the third party 
to submit the 510(k) to FDA on its behalf and to discuss its contents 
with FDA.
    3. The manufacturer's complete 510(k) conforming to FDA's 
established requirements relating to content and form of such 
submissions.
    4. A complete review of the 510(k), signed by all personnel who 
conducted the third-party review and by an individual within the third 
party responsible for supervising third-party reviews, with a 
recommendation concerning the substantial equivalence of the device.
    5. A certification that the third party continues to meet the 
personnel qualifications and prevention of conflict of interest 
criteria reviewed by FDA; that statements made in the third party's 
review are true and accurate to the best knowledge of the third party; 
that the third party's review is based on the 510(k) that it is 
submitting with the review; and that the third party understands that 
the submission to the government of false information is prohibited by 
18 U.S.C. 1001 and 21 U.S.C. 331(q).
    6. Any other information requested in FDA's guidance for third 
parties.
    FDA may not process a 510(k) submitted with a third-party review if 
this documentation is not included with the submission. Third-party 
reviews, along with the associated 510(k)'s, should be submitted to 
CDRH's Document Mail Center (address above). If a part of the material 
submitted is in a foreign language, it should be accompanied by an 
English translation verified to be complete and accurate.

H. Basic Document Processing

    To ensure the integrity of the review process, all third-party 
review materials and the associated 510(k) are to be submitted directly 
to FDA by the third party. CDRH's Document Mail Center will receive all 
submissions, and will then route them to the appropriate review 
division in CDRH's Office of Device Evaluation. 510(k)'s reviewed and 
submitted by recognized third parties will bypass the first phases of 
FDA's normal review process, that is, the acceptance screening and 
initial scientific review, and will instead be routed directly to the 
appropriate supervisory official, typically a branch chief. The 
supervisory official will rely in part on the record of review prepared 
by the third party and will conduct a brief administrative assessment 
to determine whether the third party's review is acceptable to FDA. 
This assessment will apply the same criteria as for 510(k)'s reviewed 
entirely within FDA. If FDA has questions concerning the submission, 
the third party will be contacted. The supervisory official will 
prepare FDA's decision concerning the substantial equivalence of the 
device. Decision letters and other significant correspondence will be 
sent to the third party's official correspondent, which will be 
responsible for communicating with the manufacturer. FDA is 
establishing a 30-day performance goal for its decisions on 510(k)'s 
received under the pilot program.
    As noted earlier, 510(k)'s submitted by third parties that have not 
been recognized by the agency will be accepted, but those submissions 
will not be eligible for processing under the pilot program's 
simplified procedures. Any such 510(k) will be processed in the same 
manner as a normal 510(k) submitted by a consultant.

I. Confidentiality of Information

    A recognized third party is to conscientiously preserve and protect 
the confidentiality of all information provided to it by a manufacturer 
or by FDA. Except for authorized FDA employees or as otherwise provided 
by Federal or State law, no information pertaining to any review, 
including its existence, is to be made available to any person without 
the express written permission of the manufacturer employing the third 
party and written permission by FDA.
    The releasability of third-party review information submitted to 
FDA will be determined by FDA in accordance with the agency's 
regulations (part 20 (21 CFR part 20) and Sec. 807.95) implementing the 
Freedom of Information Act and related acts. In general, 510(k) reviews 
submitted by third parties (just like reviews conducted by FDA staff) 
will be available for disclosure by FDA after FDA has issued a 
substantial equivalence decision for a device, unless the information 
is exempt from public disclosure under part 20. If necessary, a review 
will be provided to the manufacturer for predisclosure notification 
pursuant to Sec. 20.61. In addition, information submitted by a third 
party to obtain FDA's recognition for participation in the pilot 
program will be available for disclosure by FDA, unless exempt under 
part 20.

J. Records

    A recognized third party should maintain complete records of its 
510(k) reviews and other information necessary for participation in the 
pilot program. These records include documentation of the third party's 
policies and procedures under section II.D. of this document with 
respect to personnel qualifications and prevention of conflicts of 
interest; copies of all correspondence and other information to become 
recognized by FDA; copies of all 510(k) reviews, the associated 
510(k)'s, and related correspondence with manufacturers and FDA; 
information on the identity and qualifications of all personnel who 
contributed to the technical review of each 510(k); and the third 
party's fee schedule and invoices for conducting 510(k) reviews. 
Records should be in English or be accompanied by a complete and 
accurate English translation. Records should be retained for a 
reasonable period of time, but no less than 3 years following 
submission of a review to FDA. All records are subject to FDA 
inspection and copying.

K. Fees Assessed by Third Parties

    Recognized third parties may assess a reasonable fee for their 
services. The fee for a third-party review is a matter to be determined 
by contract between the third party and the manufacturer, but will be 
considered by FDA to present a conflict of interest if it is contingent 
or based upon the type of recommendation made by the third party. As 
indicated above, the third party's fee schedule and invoices for 
conducting 510(k) reviews are subject to FDA inspection and copying.

[[Page 14796]]


L. Dates and Duration of the Pilot Program

    The pilot program will begin August 1, 1996, and will run for a 2-
year period. FDA will apply the pilot program procedures to 510(k)'s 
received during this period from recognized third parties. FDA is now 
accepting applications for recognition of prospective third parties and 
will continue to do so through June 3, 1996. FDA will closely monitor 
the operation of the pilot program and may modify its scope or 
conditions if necessary to protect the public health or to better 
achieve program objectives. During the second year of the pilot 
program, FDA will evaluate the pilot program and FDA will then 
determine whether it should be continued as is, modified, or 
terminated. FDA intends to complete this evaluation prior to the 
scheduled ending date for the pilot program.

M. Safeguards

    The pilot program includes a number of safeguards to maintain a 
high level of quality in 510(k)'s reviewed by recognized third parties 
and to minimize risks to the public. Most of these safeguards have been 
discussed above, and are briefly listed here:
     Limitation of the pilot program to low- to moderate-risk 
class I or class II devices for which FDA has made review guidance 
available;
     Exclusion of any 510(k) that requires clinical data for a 
determination of substantial equivalence;
     FDA assessment and recognition of third parties before 
their participation in the pilot program;
     Personnel qualifications for third parties equivalent to 
the level within CDRH's Office of Device Evaluation;
     Criteria to prevent potential conflicts of interest that 
might affect the review process;
     FDA training for recognized third parties;
     FDA review of third-party reviews/recommendations and 
FDA's continued responsibility for the issuance of 510(k) decisions;
     Provision for FDA inspection of records, correspondence, 
and other materials relating to any third-party review;
     FDA monitoring and evaluation of the pilot program; and
     Continued applicability of any other regulatory controls 
(e.g., medical device reporting of post-marketing adverse events) 
normally applicable to devices included in the pilot program.

III. Obtaining Additional Information

    Additional information on the pilot program can be obtained by 
contacting CDRH's DSMA at 1-800-638-2041 or 301-443-7491, both at ext. 
105, or FAX 301-443-8818. Some information will only be available on 
the DSMA Facts-on-Demand facsimile system, which is accessed by touch-
tone telephone or on the DSMA Electronic Docket, which is accessed via 
a computer with a modem. Information that DSMA will make available 
includes:
     This notice;
     Registration information for the information session to be 
held on April 15, 1996, in Rockville, MD, to review the third-party 
recognition process and criteria for prospective third parties;
     A checklist for third parties seeking FDA recognition;
     Information on the general education and experience 
requirements for FDA personnel involved in the technical review of 
510(k)'s;
     Information on the conflict of interest standards FDA 
applies to its employees;
     A list of recognized third parties, updated as necessary 
(this information will only be available from the DSMA Facts-on-Demand 
system (1-800-899-0381, document number 967) or Electronic Docket (1-
800-252-1366);
     A list of the devices eligible for third-party review, 
updated at least quarterly;
     Device-specific guidance for class II devices designated 
as eligible for third-party review;
     General guidance on 510(k) requirements and the content 
and format of third-party reviews; and
     Any additional information and guidance that FDA finds 
necessary or appropriate as the pilot program proceeds.

IV. Paperwork Reduction Act of 1995

    This voluntary pilot program contains information collections which 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(Pub. L. 104-13). At the agency's request, OMB conducted an emergency 
review of this information collection, as provided for under 5 CFR 
1320.13. OMB approved the information collection within 10 days, as 
requested by FDA, for the maximum 90 days permitted under 5 CFR 
1320.13, under OMB control no. 0910-0318. Persons are not required to 
respond to a collection of information unless it displays a currently 
valid OMB control number.
    Because the OMB emergency approval of this information collection 
is valid for only 90 days, FDA is also taking the appropriate steps to 
obtain a regular approval. Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide a 60-day notice in the Federal Register concerning 
each collection of information. ``Collection of information'' is 
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c).
    To comply with this requirement, FDA is publishing a notice of the 
information collection. The title, description, and respondent 
description of the information collection are shown below with an 
estimate of the annual reporting and recordkeeping burden. Included in 
the estimate is the time for reviewing instructions, searching data 
sources, gathering and maintaining the date needed, and completing and 
reviewing the collection of information.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility; (2) the 
accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) ways to minimize 
the burden of the collection of information on those who are to 
respond, including through the use of automated collection techniques, 
when appropriate, and other forms of information technology.
    Title: Medical Devices; Third-Party Review of Selected Premarket 
Notifications; Pilot Program
    Description: This Federal Register notice announces a 2-year, 
voluntary pilot program to test the feasibility of using third-party 
reviews to improve the efficiency of FDA's review of premarket 
notifications under section 510(k) of the act. Participation is 
entirely voluntary. A third party wishing to participate will submit a 
request for recognition within 60 days of publication of the Federal 
Register notice. After reviewing a manufacturer's 510(k), a third party 
is to forward the 510(k) along with the third party's documented review 
and recommendation to FDA. Third parties should maintain records of 
their 510(k) reviews for a reasonable period of time, but no less than 
3 years. This information collection will enable FDA to conduct a 
voluntary pilot program to determine the feasibility of third-party 
review of 510(k)'s to improve the efficiency of FDA's review of 
510(k)'s for low- to moderate-risk devices.
    Description of Respondents: Businesses or other for-profit, not-
for-profit institutions.

[[Page 14797]]


                                                                                                                                                        
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Table 1.--Estimated Annual Reporting Burden for Third Parties                                             
---------------------------------------------------------------------------------------------------------------------------------------------------------
                                        No. of       Annual Frequency per   Total Annual    Hours Per       Total    Total Capital    Total Operating & 
              Section                 Respondents          Response          Responses       Response       Hours        Costs        Maintenance Costs 
--------------------------------------------------------------------------------------------------------------------------------------------------------
II.C.1-5 (Recognition Requests):                                                                                                                        
   First Submission                 15              0.51                   7.5            24             180         .............  ....................
   Additional information           8               0.51                   4.0            4              16          .............  ....................
   Updates                          10              1.0                    10.0           1              10          .............  ....................
 510(k) Reviews                                                                                                                                         
  II.G.1-6                          10              50                     500            40             20,000      57,250         28,625              
Total                               ..............  .....................  .............  .............  20,206      57,250         28,625              
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\These submissions are made in the first year only, the reporting frequency has been averaged over the pilot program's 2-year period to provide an    
  annual frequency.                                                                                                                                     


                                                                                                                                                                                                
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Table 2.--Estimated Annual Recordkeeping Burden                                                                        
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 Annual Frequency per                                                                                              Total Operating & Maintenance
      Section        No. of Recordkeepers           Recordkeeping         Total Annual Records   Hours Per Recordkeeper      Total Hours      Total Capital Costs              Costs            
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
II.J.              10                        252                          2,520                 63                        630                ....................  .............................
                   ........................  ...........................  ....................  ........................  .................  ....................  .............................
                   ........................  ...........................  ....................  ........................  .................  ....................  .............................
                   ........................  ...........................  ....................  ........................  .................  ....................  .............................
                   ........................  ...........................  ....................  ........................  .................  ....................  .............................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Capital costs and operating and maintenance costs are attributable 
to reporting and are included in the table above.
    Organizations and individuals may submit comments regarding this 
information collection, including suggestions for reducing this burden, 
by June 3, 1996, and should direct them to the Dockets Management 
Branch (address above).

    Dated: March 25, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-8149 Filed 4-1-96; 8:45 am]
BILLING CODE 4160-01-F