[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Proposed Rules]
[Pages 26129-26137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12610]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 804

[Docket No. 98N-0170]


Medical Device Reporting: Manufacturer Reporting, Importer 
Reporting, User Facility Reporting, and Distributor Reporting; 
Companion Document to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
certain regulations governing reporting by manufacturers, importers, 
distributors, and health care (user) facilities of adverse events 
related to medical devices. This proposed rule is a companion document 
to the direct final rule, published elsewhere in this issue of the 
Federal Register. The amendments are intended to implement provisions 
of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the 
Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is 
publishing this companion proposed rule under FDA's usual procedures 
for notice and comment to provide a procedural framework to finalize 
the rule in the event the agency receives a significant adverse comment 
and withdraws the direct final rule.
DATES:  Submit written comments on or before July 27, 1998. Submit 
written comments on the information collection requirements on or 
before July 13, 1998.

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

FOR FURTHER INFORMATION CONTACT:  Patricia A. Spitzig, Center for 
Devices and Radiological Health (HFZ-500), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-2812.

SUPPLEMENTARY INFORMATION: This proposed rule is a companion to the 
direct final rule published in the final rules section of this issue of 
the Federal Register. This companion proposed rule is substantively 
identical to the direct final rule. This proposed rule will provide a 
procedural framework to finalize the rule in the event the agency 
receives a significant adverse comment and the direct final rule is 
withdrawn. FDA is publishing the direct final rule

[[Page 26130]]

because the rule contains noncontroversial changes, and FDA anticipates 
that it will receive no significant adverse comments. A detailed 
discussion of this rule is set forth in the preamble of the direct 
final rule. If no significant comment is received in response to the 
direct final rule, no further action will be taken related to this 
proposed rule. Instead, FDA will publish a confirmation notice within 
30 days after the comment period ends confirming that the direct final 
rule will go into effect on September 24, 1998. Additional information 
about FDA's direct final rulemaking procedures is set forth in a 
guidance published in the Federal Register of November 21, 1997 (62 FR 
62466).
    If FDA receives a significant adverse comment regarding this rule, 
the agency will publish a document withdrawing the direct final rule 
within 30 days after the comment period ends and will proceed to 
respond to the comments under this rule using usual notice-and-comment 
procedures. The comment period for this companion proposed rule runs 
concurrently with the direct final rule's comment period. Any comments 
received under this companion proposed rule will also be considered as 
comments regarding the direct final rule. A significant adverse comment 
is defined as a comment that explains why the rule would be 
inappropriate, including challenges to the rule's underlying premise or 
approach, or would be ineffective or unacceptable without a change. In 
determining whether a significant adverse comment is sufficient to 
terminate a direct final rulemaking, FDA will consider whether the 
comment raises an issue serious enough to warrant a substantive 
response in a notice-and-comment process. Comments that are frivolous, 
insubstantial, or outside the scope of the rule will not be considered 
adverse under this procedure. For example, a comment recommending a 
rule change in addition to the rule will not be considered a 
significant adverse comment, unless the comment states why the rule 
would be ineffective without the additional change. In addition, if a 
significant adverse comment applies to part of a rule and that part can 
be severed from the remainder of the rule, FDA may adopt as final those 
parts of the rule that are not the subject of a significant adverse 
comment.
    This action is part of FDA's continuing effort to achieve the 
objectives of the President's ``Reinventing Government'' initiative, 
and is intended to reduce the burden of unnecessary regulations on 
medical devices without diminishing the protection of public health.

I. Background

    Under the act and the Medical Device Amendments of 1976 (Pub. L. 
94-295) (the 1976 amendments), FDA issued medical device reporting 
regulations for manufacturers on September 14, 1984 (49 FR 36326). To 
correct weaknesses noted in the 1976 amendments, and to better protect 
the public health by increasing reports of device-related adverse 
events, Congress enacted the Safe Medical Devices Act of 1990 (Pub. L. 
101-629) that required medical device user facilities and distributors 
to report certain device-related adverse events.
    Distributor reporting requirements became effective on May 28, 
1992, following the November 26, 1991, publication of those provisions 
in a tentative final rule (56 FR 60024). In the Federal Register of 
September 1, 1993 (58 FR 46514), FDA published a notice announcing that 
the proposed distributor reporting regulations had become final by 
operation of law and were now codified in part 804 (21 CFR part 804).
    On June 16, 1992, the President signed into law the Medical Device 
Amendments of 1992 (the 1992 amendments) (Pub. L. 102-112) amending 
certain provisions of section 519 of the act (21 U.S.C. 360i) relating 
to reporting of adverse device events. Prior to the 1992 amendments, 
distributors and manufacturers reported adverse events by using a 
``reasonable probability'' standard. Importers may be manufacturers or 
distributors, depending on their activities. Among other things, the 
1992 amendments amended section 519 to change the reporting standard 
for manufacturers and importers, however, the reporting standard for 
distributors who are not importers remained the same.
    On November 21, 1997, the President signed FDAMA into law. FDAMA 
made several changes regarding the reporting of adverse events related 
to devices, including the elimination of reporting requirements for 
certain distributors, which became effective on February 19, 1998, that 
are reflected in this proposed rule. However, section 422 of FDAMA 
states that FDA's regulatory authority under the act, relating to 
tobacco products, tobacco ingredients, and tobacco additives shall be 
exercised under the act as in effect on the day before the date of 
enactment of FDAMA. Because the authority relating to tobacco products 
remains the same, the reporting requirements for manufacturers and 
distributors (including distributors who are importers) of cigarettes 
or smokeless tobacco remain unchanged.
    Under part 897, the regulations pertaining to tobacco products, and 
parts 803 and 804, the regulations pertaining to device adverse event 
reporting, importers may be either manufacturers or distributors, 
depending on their activities. Under parts 897, 803, and 804, importers 
who repackage or relabel are manufacturers. Similarly, under those 
sections, importers whose sole activity is distribution of devices are 
defined as distributors.
    As previously stated, the 1992 amendments created a bifurcated 
reporting standard for distributors, depending on whether they are 
domestic distributors or importers. When the agency asserted 
jurisdiction over tobacco products and issued regulations under part 
897, tobacco distributors also became subject to this bifurcated 
reporting standard. Accordingly, the reporting standard applicable to 
tobacco products distributors has depended on whether the distributor 
is domestic or an importer. Consistent with section 422 of FDAMA, the 
proposed rule states that tobacco distributors will continue to use the 
appropriate reporting standard as described in Sec. 804.25.
    Changes made by FDAMA relating to reporting requirements for all 
medical devices other than tobacco products are as follows:
    1. Section 213(a) of FDAMA revised section 519(a) of the act to 
eliminate distributors as an entity required to report adverse device 
events. Importers are still required to report under section 519(a) of 
the act.
    2. Section 213(a) also amended section 519(a) of the act to clarify 
that existing requirements continue to apply for distributors to keep 
records concerning adverse device events and to make them available to 
FDA upon request.
    3. Section 213(a)(2) revoked section 519(d) of the act, which 
required manufacturers, importers, and distributors to submit to FDA an 
annual certification concerning the number of reports filed under 
section 519(a) in the preceding year. As a result, certification 
requirements are eliminated.
    4. Section 213(c)(1)(A) of FDAMA revised section 519(b)(1)(C) of 
the act to require that device user facilities submit an annual rather 
than a semiannual summary of their reports to FDA.
    5. Section 213(c)(1)(B) of FDAMA eliminated section 519(b)(2)(C) of 
the act. This section had required FDA to

[[Page 26131]]

disclose, upon request, the identity of a user facility making a report 
under section 519(b), if the identity of the user facility was included 
in a report submitted by a manufacturer, distributor, or importer. As a 
result of this change by FDAMA, FDA may now disclose the identity of a 
user facility only in connection with an action concerning a failure to 
report or false or fraudulent reporting, in a communication to the 
manufacturer of the device, or to the employees of the Department of 
Health and Human Services, the Department of Justice, and duly 
authorized committees and subcommittees of Congress.
    To implement these provisions, FDA is issuing this proposed rule. A 
summary of the rule is contained in the preamble to the direct final 
rule published elsewhere in this issue of the Federal Register.

II. 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.

III. Analysis of Impacts

    FDA has examined the impact of the proposed rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995 
(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 agency believes that this proposed rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, this proposed rule is not a significant regulatory 
action as defined by the Executive Order and so is not subject to 
review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The proposed rule would eliminate reporting by 
distributors, other than distributors (including distributors who are 
importers) of cigarettes or smokeless tobacco, continue reporting by 
importers (including distributors who are importers), increase 
protections from disclosure of the identity of device user facilities 
that have submitted reports, reduce summary reporting by device user 
facilities from semiannual to annual, eliminate annual certification 
for manufacturers and distributors (including importers) of medical 
devices other than cigarettes or smokeless tobacco, and make other 
nonsubstantive changes. The agency certifies that this proposed rule 
will not have a significant economic impact on a substantial number of 
small entities. This proposed rule also does not trigger the 
requirement for a written statement under section 202(a) of the 
Unfunded Mandates Reform Act because it does not impose a mandate that 
results in an expenditure of $100 million or more by State, local, or 
tribal governments in the aggregate, or by the private sector, in any 1 
year.

IV. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection provisions are shown as follows with an estimate of the 
annual reporting and recordkeeping burden. Included in the estimate is 
the time for reviewing the instructions, searching existing data 
sources, gathering and maintaining the data needed, and completing and 
reviewing each collection of information. FDA invites comments on: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of FDA's functions, including whether the 
information will have practical utility; (2) the accuracy of FDA'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 respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology.
    Title: Reporting and recordkeeping requirements for manufacturers, 
importers, user facilities, and distributors of medical devices under 
FDAMA.
    Description: FDAMA contained provisions that affect medical device 
reporting in a variety of ways. Section 213 of FDAMA modified the 
summary reporting requirements for user facilities to require annual, 
rather than semiannual, reporting, and increased confidentiality of 
user facility identities. This section of FDAMA also eliminated the 
reporting requirements for medical device distributors (but not for 
importers), as well as the certification requirements for medical 
device manufacturers and distributors. However, section 422 of FDAMA 
states that FDA's regulatory authority under the act relating to 
tobacco products, tobacco ingredients, and tobacco additives shall be 
exercised under the act as in effect on the day before the date of 
enactment of FDAMA. Under this rule of construction, the reporting and 
certification requirements for manufacturers and distributors 
(including distributors who are importers) of cigarettes or smokeless 
tobacco remain unchanged.
     This proposed rule would amend FDA's regulations in 21 CFR Parts 
803 and 804 to reflect the changes to medical device reporting made by 
FDAMA.
     This proposed rule would eliminate reporting by distributors other 
than distributors of cigarettes or smokeless tobacco, continue 
reporting by importers, increase the protection from disclosure of the 
identity of device user facilities that have submitted reports, reduce 
summary reporting by device user facilities from semiannual to annual, 
eliminate annual certification for manufacturers and distributors 
(including importers) of medical devices other than cigarettes or 
smokeless tobacco, and make other nonsubstantive changes.
    Description of Respondents: Businesses or other for profit 
organizations.
    FDA estimates the burden for this collection of information as 
follows:

[[Page 26132]]



                                                       Table 1.--Estimated Annual Reporting Burden                                                      
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   21 CFR                                    No. of Responses per                                                                                       
   Section        No. of Respondents              Respondent            Total Annual Responses        Hours per Response              Total Hours       
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803.19        150                         1                           150                         3                           450                       
803.33        1,800                       1                           1,800                       1                           1,800                     
803.40        195                         1                           195                         3                           585                       
803.56        750                         20                          15,000                      1                           15,000                    
803.57        31                          1                           31                          1                           31                        
804.25        10                          1                           10                          1.5                         15                        
804.30         1,365                      1                           1,365                       1                           1,365                     
804.32        5                           1                           5                           1                           5                         
804.33        0                           0                           0                           1                           0                         
Total         ..........................  ..........................  ..........................  ..........................  19,251                    
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                                                     Table 2.--Estimated Annual Recordkeeping Burden                                                    
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   21 CFR                                    Annual Frequency per                                                                                       
   Section       No. of Recordkeepers            Recordkeeping           Total Annual Records       Hours per Recordkeeper            Total Hours       
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.17        2,000                       1                           2,000                       2                           4,000                     
803.18        39,764                      1                           39,764                      1.5                         59,646                    
804.34        1,365                       1                           1,365                       1                           1,365                     
804.35        1,365                       1                           1,365                       1.5                         2,047                     
Total         ..........................  ..........................  ..........................  ..........................  67,058                    
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Note: There are no operating and maintainance cost or capital costs associated with this collection of information.                                     

    The burdens under this proposed rule are explained as follows:

A. Reporting Requirements

    Prior to the program change proposed in this rule, Sec. 803.19 
allowed manufacturers or user facilities to request an exemption or 
variance from the reporting requirements. The agency had estimated that 
it would receive approximately 100 such requests annually. Distributors 
(including importers) were able to request an exemption or variance 
from the reporting requirements under Sec. 804.33. Under this proposed 
rule, Sec. 803.19 would be modified to transfer the exemption 
provisions for importers of medical devices other than cigarettes or 
smokeless tobacco from Sec. 804.33 to Sec. 803.19. Furthermore, 
distributors (who are not importers) of medical devices other than 
cigarettes or smokeless tobacco would no longer be required to submit 
MDR reports under this proposed rule. The estimated burden for 
Sec. 803.19 is further adjusted to reflect the agency's actual 
experience with this type of submission.
    Prior to the program change proposed in this rule, Sec. 803.33 
required medical device user facilities to submit summary reports 
semiannually. Under this proposed rule, user facilities would be 
required to submit summary reports annually, thereby significantly 
decreasing the reporting burden on user facilities. The estimated 
burden for this section is also adjusted to reflect the agency's actual 
experience with this type of submission.
    Under this proposed rule the reporting requirement for importers of 
medical devices other than cigarettes or smokeless tobacco previously 
codified under Sec. 804.25 would be transferred to new proposed 
Sec. 803.40. The estimated burden for importer reporting is based upon 
the agency's actual experience with this type of submission. The 
reporting requirements for distributors (including distributors who are 
importers) of cigarettes or smokeless tobacco would be retained in part 
804.
    Prior to the program change proposed in this rule, Sec. 803.56 
required manufacturers to submit supplemental reports containing 
information not known or not available at the time the initial report 
was submitted. The agency had estimated that it would receive 
approximately 500 such requests annually. Distributors (including 
distributors who are importers) were required to submit supplemental 
information under Sec. 804.32. Under this proposed rule, Sec. 803.56 
would be modified to transfer the supplemental reporting requirements 
for importers of medical devices other than cigarettes or smokeless 
tobacco from Sec. 804.32. Furthermore, distributors (who are not 
importers) of medical devices other than cigarettes or smokeless 
tobacco would no longer be required to submit MDR reports (and thus 
supplemental reports as well) under this proposed rule. The estimated 
burden for Sec. 803.56 is further adjusted to reflect the agency's 
actual experience with this type of submission. The agency also notes 
that any additional information requested by the agency in accordance 
with Sec. 803.15 is considered to be supplemental information for the 
purpose of this information collection and is included in the burden 
estimate for Sec. 803.56.
    Prior to the program change proposed in this rule, Sec. 803.57 
required medical device manufacturers to annually certify as to the 
number of reports submitted during the previous year, or that no such 
reports had been submitted. Distributors (including importers) were 
required to certify under Sec. 804.30. Under this proposed rule, 
Sec. 803.57 would be modified to require annual certification only for 
manufacturers of cigarettes or smokeless tobacco. The certification 
requirements for distributors (including distributors who are 
importers) of cigarettes or smokeless tobacco would be retained in 
Sec. 804.30.
    Prior to the program change proposed in this rule, Sec. 804.25 
required medical device distributors (including importers) to report 
adverse device events. Under this proposed rule, distributors of 
medical devices other than cigarettes or smokeless tobacco are no 
longer required to submit MDR reports, and the reporting requirements 
for importers of medical devices other than cigarettes or smokeless 
tobacco would be transferred to part 803. Section 804.25 would require 
distributors (including distributors who are importers) of cigarettes 
or smokeless tobacco to submit MDR reports for adverse events related 
to contamination of their products. The agency believes that there will 
be a very small number of MDR reports related to contamination

[[Page 26133]]

of cigarettes or smokeless tobacco submitted in any given year.
    Prior to the program change proposed in this rule, Sec. 804.30 
required medical device distributors (including importers) to certify 
as to the number of MDR reports submitted during the previous year, or 
that no such reports were submitted. Under this rule, the certification 
requirement has been removed for distributors (including distributors 
who are importers) of medical devices other than cigarettes or 
smokeless tobacco. Section 804.30 now would require distributors 
(including distributors who are importers) of cigarettes or smokeless 
tobacco to submit certifications of the number of MDR reports submitted 
for adverse events related to contamination of their products. The 
agency has identified 1,365 distributors of cigarettes or smokeless 
tobacco, each of which would submit one certification annually.
     Prior to the program change proposed in this rule, Sec. 804.32 
required medical device distributors (including importers) to submit 
supplemental information related to a previously submitted MDR report. 
Under this proposed rule, distributors of medical devices other than 
cigarettes or smokeless tobacco are no longer required to submit any 
MDR reports, and the reporting requirements for importers of medical 
devices other than cigarettes or smokeless tobacco would be transferred 
to part 803. Section 804.32 would require distributors (including 
distributors who are importers) of cigarettes or smokeless tobacco to 
submit supplemental information related to a previously submitted MDR 
report. Because the agency believes that there will be a very small 
number of MDR reports related to contamination of cigarettes or 
smokeless tobacco submitted in any given year, even fewer supplemental 
submissions are anticipated. The agency also notes that any additional 
information requested by the agency in accordance with section 804.31 
is considered to be supplemental information for the purpose of this 
information collection and is included in the burden estimate for 
Sec. 804.32.
     Prior to the program change proposed in this rule, Sec. 804.33 
allowed medical device distributors (including importers) to request an 
exemption or variance from the reporting requirements. Under this rule, 
the exemption provisions for importers of medical devices other than 
cigarettes or smokeless tobacco would be transferred to Sec. 803.19, 
and distributors (who are not importers) of medical devices other than 
cigarettes or smokeless tobacco are no longer required to submit any 
MDR reports under this rule. Section 804.33 would allow distributors 
(including distributors who are importers) of cigarettes or smokeless 
tobacco to request an exemption or variance from the reporting 
requirements. However, because distributors (including distributors who 
are importers) of cigarettes or smokeless tobacco are required only to 
submit reports of adverse events related to contamination of their 
products, the agency does not anticipate any requests for exemptions or 
variances from the reporting requirements.

 B. Recordkeeping Requirements

    Prior to the program change proposed in this rule, Sec. 803.17 
required manufacturers and user facilities to establish written 
procedures for employee education, complaint processing, and 
documentation of information related to MDR's. Under this proposed 
rule, the requirement for establishing written MDR procedures for 
importers of medical devices other than cigarettes or smokeless tobacco 
would be transferred to Sec. 803.17, and the requirements for 
distributors (including importers) of medical devices other than 
cigarettes of smokeless tobacco would be retained in Sec. 804.34. The 
agency believes that the majority of manufacturers, user facilities, 
and importers have already established written procedures to document 
complaints and information related to MDR reporting as part of their 
internal quality control system. The agency has estimated that no more 
than 2,000 such entities would be required to establish new procedures, 
or revise existing procedures, in order to comply with this provision. 
For those entities, a one-time burden of 10 hours, annualized over a 
period of 5 years, is estimated for establishing written MDR 
procedures. The remainder of manufacturers, user facilities and 
importers not required to revise their written procedures to comply 
with this provision are excluded from the burden because the 
recordkeeping activities needed to comply with this provision are 
considered ``usual and customary'' under 5 CFR 1320.3(b)(2).
     Prior to the program change proposed in this rule, Sec. 803.18 
required manufacturers and user facilities to establish and maintain 
MDR event files. Distributors (including importers) were required to 
establish and maintain MDR event files under Sec. 804.35. Under this 
proposed rule, Sec. 803.18 would be modified to transfer the 
recordkeeping requirements for importers and other distributors of 
medical devices other than cigarettes or smokeless tobacco from 
Sec. 804.35. Recordkeeping requirements for distributors (including 
distributors who are importers) of cigarettes or smokeless tobacco 
would be retained in Sec. 804.35.
    Prior to the program change proposed in this rule, Sec. 804.34 
required distributors (including importers) of all medical devices to 
establish written procedures for employee education, complaint 
processing and documentation of information related to MDR reports. 
Under this proposed rule, distributors of medical devices other than 
cigarettes or smokeless tobacco would no longer be required to submit 
MDR reports although distributors are required to establish device 
complaint files in accordance with 21 CFR 820.198. Accordingly, they 
would no longer be subject to the requirement to establish and maintain 
written MDR procedures. Under the proposed rule, the requirement for 
establishing written MDR procedures for importers of medical devices 
other than cigarettes or smokeless tobacco would be transferred to 
Sec. 803.17, and the requirements for distributors (including 
distributors who are importers) of cigarettes or smokeless tobacco 
would be retained in Sec. 804.34. The agency has estimated a one-time 
burden of 10 hours, annualized over a period of 5 years, for 
distributors (including distributors who are importers) of cigarettes 
or smokeless tobacco to establish written MDR procedures under 
Sec. 804.34.
    Prior to the program change proposed in this rule, Sec. 804.35 
required distributors (including importers) to establish and maintain 
MDR event files. Under this proposed rule, the recordkeeping burdens 
for distributors (including importers) of medical devices other than 
cigarettes or smokeless tobacco would be transferred to Sec. 803.18. 
Recordkeeping requirements for distributors (including distributors who 
are importers) of cigarettes or smokeless tobacco would be retained in 
Sec. 804.35.
     For consistency with the direct final rule to which this proposed 
rule is a companion, FDA is following the Paperwork Reduction Act 
comment procedures for direct final rules in this proposed rule. As 
provided in 5 CFR 1320.5(c)(1), collections of information in a direct 
final rule are subject to the procedures set forth in 5 CFR 1320.10. 
Interested persons and organizations may submit comments on the 
information collection provisions of this proposed rule July 13, 1998 
to the Dockets Management Branch (address above).

[[Page 26134]]

    At the close of the 60 day comment period, FDA will review the 
comments received, revise the information collection provisions as 
necessary, and submit these provisions to OMB for review. FDA will 
publish a notice in the Federal Register when the information 
collection provisions are submitted to OMB, and an opportunity for 
public comment to OMB will be provided at that time. Prior to the 
effective date of the direct final rule, FDA will publish a notice in 
the Federal Register of OMB's decision to approve, modify, or 
disapprove the information collection provisions. An agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.

V. Request for Comments

    Interested persons may, on or before July 27, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this companion proposed rule. The comment period runs concurrently with 
the comment period for the direct final rule. 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 the 
brackets in the heading of this document. Comments will be considered 
to determine whether to amend or revoke this proposed rule. Received 
comments may be seen in the office above between 9 a.m. and 4 p.m., 
Monday through Friday. All comments received will be considered as 
comments regarding the direct final rule and this proposed rule. In the 
event the direct final rule is withdrawn, all comments received 
regarding the direct final rule and this companion proposed rule will 
be considered comments on this proposed rule.

List of Subjects in 21 CFR Parts 803 and 804

    Imports, Medical devices, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 803 and 804 be amended as follows:

PART 803--MEDICAL DEVICE REPORTING

    1. The authority citation for 21 CFR part 803 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

    2. Section 803.1 is amended by revising paragraph (a) to read as 
follows:


Sec. 803.1  Scope.

    (a) This part establishes requirements for medical device 
reporting. Under this part, device user facilities, importers, and 
manufacturers, as defined in Sec. 803.3, must report deaths and serious 
injuries to which a device has or may have caused or contributed, must 
establish and maintain adverse event files, and must submit to FDA 
specified followup and summary reports. Medical device distributors, as 
defined in Sec. 803.3, are also required to maintain incident files. 
Furthermore, manufacturers and importers are also required to report 
certain device malfunctions. These reports will assist FDA in 
protecting the public health by helping to ensure that devices are not 
adulterated or misbranded and are safe and effective for their intended 
use.
* * * * *
    3. Section 803.3 is amended by redesignating paragraphs (m) through 
(ee) as paragraphs (n) through (ff), respectively; by revising the last 
sentence of the introductory text of paragraph (c), paragraph (c)(1), 
and redesignated paragraphs (p), (p)(1), and (r)(2); and by adding 
paragraphs (g) and (m) to read as follows:


Sec. 803.3  Definitions.

* * * * *
    (c) * * * Manufacturers and importers are considered to have become 
aware of an event when:
    (1) Any employee becomes aware of a reportable event that is 
required to be reported by an importer within 10 days, or by a 
manufacturer within 30 days or within 5 days under a written request 
from FDA under Sec. 803.53(b); and
* * * * *
    (g) Distributor means, for the purposes of this part, any person 
(other than the manufacturer or importer) who furthers the marketing of 
a device from the original place of manufacture to the person who makes 
final delivery or sale to the ultimate user, but who does not repackage 
or otherwise change the container, wrapper or labeling of the device or 
device package. One who repackages or otherwise changes the container, 
wrapper, or labeling, is a manufacturer under Sec. 803.3(o). For the 
purposes of this part, distributors do not include distributors of 
cigarettes or smokeless tobacco.
* * * * *
    (m) Importer means, for the purposes of this part, any person who 
imports a device into the United States and who furthers the marketing 
of a device from the original place of manufacture to the person who 
makes final delivery or sale to the ultimate user, but who does not 
repackage or otherwise change the container, wrapper, or labeling of 
the device or device package. One who repackages or otherwise changes 
the container, wrapper, or labeling, is a manufacturer under 
Sec. 803.3(o). For the purposes of this part, importers do not include 
importers of cigarettes or smokeless tobacco.
* * * * *
    (p) Manufacturer or importer report number means the number that 
uniquely identifies each individual adverse event report submitted by a 
manufacturer or importer. This number consists of three parts as 
follows:
    (1) The FDA registration number for the manufacturing site of the 
reported device, or for the importer. (If the manufacturing site or the 
importer does not have a registration number, FDA will assign a 
temporary number until the site is officially registered. The 
manufacturer or importer will be informed of the temporary number.);
* * * * *
    (r) * * *
    (2) An event about which manufacturers or importers have received 
or become aware of information that reasonably suggests that one of 
their marketed devices:
    (i) May have caused or contributed to a death or serious injury; or
    (ii) Has malfunctioned and that the device or a similar device 
marketed by the manufacturer or importer would be likely to cause a 
death or serious injury if the malfunction were to recur.
* * * * *


Sec. 803.9  [Amended]

    4. Section 803.9 Public availability of reports is amended by 
adding ``or'' after the semicolon at the end of paragraph (c)(2), by 
removing paragraph (c)(3), and by redesignating paragraph (c)(4) as 
paragraph (c)(3).
    5. Section 803.10 is amended by revising the heading and paragraphs 
(a)(2) and (c)(5), and by adding paragraph (b) to read as follows:


Sec. 803.10  General description of reports required from user 
facilities, importers, and manufacturers.

    (a) * * *
    (2) User facilities must submit annual reports as described in 
Sec. 803.33.
    (b) Importers must submit MDR reports of individual adverse events 
within 10 working days after the importer becomes aware of an MDR 
reportable event as described in Sec. 803.3. Importers must submit 
reports of device-related deaths or serious injuries to FDA and the 
manufacturer and reports of malfunctions to the manufacturer.

[[Page 26135]]

    (c) * * *
    (5) For manufacturers of cigarettes or smokeless tobacco, annual 
certification to FDA of the number of MDR reports filed during the 
preceding year as described in Sec. 803.57.


Sec. 803.11  [Amended]

    6. Section 803.11 Obtaining the forms is amended in the first 
sentence by adding the word
 ``, importers,'' after the phrase ``User facilities''.
    7. Section 803.12 is amended by revising paragraph (b) to read as 
follows:

Sec. 803.12  Where to submit reports.

* * * * *
    (b) Each report and its envelope shall be specifically identified, 
e.g., ``User Facility Report,'' ``Annual Report,'' ``Importer Report,'' 
``Manufacturer Report,'' ``5-Day Report,'' ``Baseline Report,'' etc.


Sec. 803.17  [Amended]

    8. Section 803.17 Written MDR procedures is amended in the 
introductory paragraph by adding the word ``, importers,'' after the 
phrase ``User facilities''.
    9. Section 803.18 is amended by revising the heading, the first 
sentence of paragraphs (a) and (b)(1) introductory text, paragraphs 
(b)(1)(ii) and (b)(2), and the second sentence of paragraph (c), and by 
adding paragraph (d) to read as follows:


Sec. 803.18  Files and distributor records.

    (a) User facilities, importers, and manufacturers shall establish 
and maintain MDR event files. * * *
    (b)(1) For purposes of this part, ``MDR event files'' are written 
or electronic files maintained by user facilities, importers, and 
manufacturers. * * *
    (ii) Copies of all MDR forms, as required by this part, and other 
information related to the event that was submitted to FDA and other 
entities (e.g., an importer, distributor, or manufacturer).
    (2) User facilities, importers, and manufacturers shall permit any 
authorized FDA employee during all reasonable times to access, to copy, 
and to verify the records required by this part.
    (c) * * * Manufacturers and importers shall retain an MDR event 
file relating to an adverse event for a period of 2 years from the date 
of the event or a period of time equivalent to the expected life of the 
device, whichever is greater. * * *
    (d)(1) A device distributor shall establish device complaint files 
in accordance with Sec. 820.198 of this chapter and maintain an 
incident record containing any information, including any written or 
oral communication, that alleges deficiencies related to the identity, 
quality, durability, reliability, safety, effectiveness, or performance 
of a device. Device incident records shall be prominently identified as 
such and shall be filed by device.
    (2) A device distributor shall retain copies of the records 
required to be maintained under this section for a period of 2 years 
from the date of inclusion of the record in the file or for a period of 
time equivalent to the design and expected life of the device, 
whichever is greater, even if the distributor has ceased to distribute 
the device that is the subject of the record.
    (3) A device distributor shall maintain the device complaint files 
established under this section at the distributor's principal business 
establishment. A distributor that is also a manufacturer may maintain 
the file at the same location as the manufacturer maintains its 
complaint file under Secs. 820.180 and 820.198 of this chapter. A 
device distributor shall permit any authorized FDA employee, during all 
reasonable times, to have access to, and to copy and verify, the 
records required by this part.


Sec. 803.19  [Amended]

    10. Section 803.19 Exemptions, variances, and alternative reporting 
requirements is amended by adding in paragraphs (b) and (c) the word 
``, importers,'' before the phrase ``or user facility,'' and by adding 
in paragraph (c) a comma after the word ``variance''.
    11. Section 803.20 is amended by revising the last sentence of 
introductory text of paragraph (a), paragraph (a)(1), and the first 
sentence of paragraph (a)(2), and by adding paragraph (b)(2) to read as 
follows:


Sec. 803.20  How to report.

    (a) * * * The form has sections that must be completed by all 
reporters and other sections that must be completed only by the user 
facility, importer, or manufacturer.
    (1) The front of FDA Form 3500A is to be filled out by all 
reporters. The front of the form requests information regarding the 
patient, the event, the device, and the ``initial reporter'' (i.e., the 
first person or entity that submitted the information to the user 
facility, manufacturer, or importer).
    (2) The back part of the form contains sections to be completed by 
user facilities, importers, and manufacturers. * * *
    (b) * * *
    (2) Importers are required to submit MDR reports to FDA and the 
device manufacturer, except for malfunctions which are reported to the 
manufacturer only:
    (i) Within 10 working days of becoming aware of information that 
reasonably suggests that a device has or may have caused or contributed 
to a death or serious injury.
    (ii) Within 10 working days of receiving information that a device 
marketed by the importer has malfunctioned and that such a device or a 
similar device marketed by the importer would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
recur.
* * * * *


Sec. 803.22  [Amended]

    12. Section 803.22 When not to file is amended by adding in 
paragraphs (a) and (b)(1) the word ``, importer,'' after the word 
``facility''.


Sec. 803.33  [Amended]

    13. Section 803.33 Semiannual reports is amended by revising the 
heading to read ``Annual reports''; in introductory text of paragraph 
(a) by removing the phrase ``(for reports made July through December) 
and by July 1 (for reports made January through June)''; in 
introductory text of paragraph (a) and paragraphs (a)(5), (a)(7) 
introductory text, and (c) by removing the word ``semiannual'' wherever 
it appears and adding in its place the word ``annual''; in paragraph 
(a)(2) by removing the phrase ``and period, e.g., January through June 
or July through December''; and by adding in paragraph (a)(7)(vi) the 
word ``importer,'' after the word ``distributor,''.
    14. Subpart D, consisting of Secs. 803.40 and 803.43, is added to 
read as follows:

Subpart D--Importer Reporting Requirements

Sec.
803.40  Individual adverse event reporting requirements; importers.
803.43  Individual adverse event report data elements.

 Subpart D--Importer Reporting Requirements


Sec. 803.40  Individual adverse event reporting requirements; 
importers.

    (a) An importer shall submit to FDA a report, and a copy of such 
report to the manufacturer, containing the information required by 
Sec. 803.43 on FDA form 3500A as soon as practicable, but not later 
than 10 working days after the importer receives or otherwise becomes 
aware of information from any source, including user facilities, 
individuals, or medical or scientific

[[Page 26136]]

literature, whether published or unpublished, that reasonably suggests 
that one of its marketed devices may have caused or contributed to a 
death or serious injury.
    (b) An importer shall submit to the manufacturer a report 
containing information required by Sec. 803.43 on FDA form 3500A, as 
soon as practicable, but not later than 10 working days after the 
importer receives or otherwise becomes aware of information from any 
source, including user facilities, individuals, or through the 
importer's own research, testing, evaluation, servicing, or maintenance 
of one of its devices, that one of the devices marketed by the importer 
has malfunctioned and that such device or a similar device marketed by 
the importer would be likely to cause or contribute to a death or 
serious injury if the malfunction were to recur.


Sec. 803.43  Individual adverse event report data elements.

    (a) Each importer that submits a report on an MDR reportable event 
shall complete and submit the applicable portions of FDA form 3500A in 
so far as the information is known or should be known to the importer, 
and submit it to FDA, and to the manufacturer as required by 
Sec. 803.40.
    (b) Each importer shall submit the information requested on FDA 
form 3500A, including:
    (1) Identification of the source of the report.
    (i) Type of source that reported the event to the importer (e.g., 
lay user owner, lay user lessee, hospital, nursing home, outpatient 
diagnostic facility, outpatient treatment facility, ambulatory surgical 
facility);
    (ii) Importer report number;
    (iii) Name, address, and telephone number of the source that 
reported the event to the importer (e.g., distributor, user facility, 
practitioner, etc.); and
    (iv) Name of the manufacturer of the device.
    (2) Date information.
    (i) The date of the occurrence of the event;
    (ii) The date the source that reported the event to the importer 
became aware of the event;
    (iii) The date the event was reported to the manufacturer and/or 
FDA; and
    (iv) The date of this report.
    (3) The type of MDR reportable event (e.g., death, serious illness, 
serious injury, or malfunction), and whether an imminent hazard was 
involved;
    (4) Patient information including age, sex, diagnosis, and medical 
status immediately prior to the event and after the event;
    (5) Device information including brand and labeled name, generic 
name, model number or catalog number or other identifying numbers, 
serial number or lot number, purchase date, expected shelf life/
expiration date (if applicable), whether the device was labeled for 
single use, and date of implant (if applicable);
    (6) Maintenance/service information data including the last date of 
service performed on the device, where service was performed, whether 
service documentation is available, and whether service was in 
accordance with the service schedule;
    (7) Whether the device is available for evaluation and, if not, the 
disposition of the device;
    (8) Description of the event, including:
    (i) Who was operating or using the device when the event occurred;
    (ii) Whether the device was being used as labeled or as otherwise 
intended;
    (iii) The location of the event;
    (iv) Whether there was multi-patient involvement, and if so, how 
many patients were involved;
    (v) A list of any other devices whose performance may have 
contributed to the event and their manufacturers, and the results of 
any analysis or evaluation with respect to such device (or a statement 
of why no analysis or evaluation was performed); and
    (vi) A complete description of the event including, but not limited 
to, what happened, how the device was involved, the nature of the 
problem, patient followup/treatment required, and any environmental 
conditions that may have influenced the event.
    (9) The results of any analysis of the device and the event, 
including:
    (i) The method of the evaluation or an explanation of why no 
evaluation was necessary or possible;
    (ii) The results and conclusions of the evaluation;
    (iii) The corrective actions taken; and
    (iv) The degree of certainty concerning whether the device caused 
or contributed to the reported event;
    (10) The name, title, address, telephone number, and signature of 
the person who prepared the report.


Sec. 803.56  [Amended]

    15. Section 803.56 Supplemental reports is amended in the 
introductory paragraph and in paragraphs (a) and (b) by adding the 
words ``or importer'' after the word ``manufacturer''.


Sec. 803.57  [Amended]

    16. Section 803.57 Annual certification is amended in paragraphs 
(a) and (d) by removing the word ``manufacturers'' wherever it appears 
and by adding in its place the phrase ``manufacturers of cigarettes or 
smokeless tobacco'', and in paragraphs (b), (c)(1), and (d) by removing 
the word ``manufacturer'' wherever it appears and adding in its place 
the phrase ``manufacturer of cigarettes or smokeless tobacco''.

PART 804--MEDICAL DEVICE REPORTING FOR DISTRIBUTORS OF CIGARETTES 
OR SMOKELESS TOBACCO

    17. The authority citation for 21 CFR part 804 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

    18. Part 804 is amended by revising the heading to read as set 
forth above.
    19. Section 804.1 is amended by revising paragraph (a) to read as 
follows:


Sec. 804.1  Scope.

    (a) FDA is requiring distributors of cigarettes or smokeless 
tobacco to report deaths, serious illnesses, and serious injuries that 
are attributed to contamination of a cigarette or smokeless tobacco 
product. Distributors of cigarettes or smokeless tobacco are also 
required to submit a report to FDA annually certifying the number of 
medical device reports filed during the preceding year, or that no 
reports were filed. These reports enable FDA to protect the public 
health by helping to ensure that these products are not adulterated or 
misbranded and are otherwise safe and effective for their intended use. 
In addition, distributors of cigarettes or smokeless tobacco are 
required to establish and maintain complaint files or incident files as 
described in Sec. 804.35, and to permit any authorized FDA employee at 
all reasonable times to have access to, and to copy and verify, the 
records contained in this file. This part supplements, and does not 
supersede, other provisions of this subchapter, including the 
provisions of part 820 of this chapter.
* * * * *
    20. Section 804.3 is amended by revising paragraph (d), and in 
paragraphs (m)(1) and (m)(2) by adding the phrase ``related to the 
contamination of cigarettes or smokeless tobacco'' after the word 
``event'' to read as follows:


Sec. 804.3  Definitions.

* * * * *
    (d) Distributor means, for the purpose of this part, any person who 
furthers the distribution of cigarettes or smokeless tobacco, whether 
domestic or imported,

[[Page 26137]]

at any point from the original place of manufacture to the person who 
sells or distributes the product to individuals for personal 
consumption, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the product package. Common carriers 
are not considered distributors for the purposes of this part.
* * * * *


Sec. 804.25  [Amended]

    21. Section 804.25 Reports by distributors is amended in paragraph 
(a)(1) by removing the words ``a device'' and adding in their place the 
phrase ``contamination of a cigarette or smokeless tobacco product''; 
in paragraph (a)(2) by removing the phrase ``one of its marketed 
devices'' and adding in its place the phrase ``contamination of one of 
its cigarette or smokeless tobacco products''; and by removing 
paragraph (c).

    Dated: May 1, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-12610 Filed 5-11-98; 8:45 am]
BILLING CODE 4160-01-F