[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Rules and Regulations]
[Pages 26069-26077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12614]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations governing reporting by manufacturers, importers, 
distributors, and health care (user) facilities of adverse events 
related to medical devices. Amendments are being made to implement 
revisions to 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 these amendments in accordance with its 
direct final rule procedures. Elsewhere in this issue of the Federal 
Register, FDA is publishing a 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 this direct final rule.

DATES: This rule is effective September 24, 1998. 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 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:

I. Background

    Under the act and the Medical Device Amendments of 1976 (the 1976 
amendments) (Pub. L. 94-295), 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 (the 
SMDA) (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 (56 FR 60024), publication of 
those provisions in a tentative final rule. 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 of the act 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 direct final 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 (21 CFR part 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 
direct final 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 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

[[Page 26070]]

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 disclose, upon request, the 
identity of a device user facility making a report under section 519(b) 
of the act if the identity of the device user facility was included in 
a report required to be submitted by a manufacturer, distributor, or 
importer. As a result of this change by FDAMA, FDA may now disclose the 
identity of a device user facility only in connection with an action 
concerning a failure to report or false or fraudulent reporting, 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.

II. Final Rule

A. General Approach

    1. To implement these provisions, FDA is amending part 804, 
Distributor Reporting, to reflect that the distributor reporting 
requirements under that part remain in effect only for distributors 
(including distributors who are importers) of cigarettes or smokeless 
tobacco, as defined in part 897. FDA is revoking the reporting 
requirements under parts 803 and 804 as they apply to distributors who 
are not importers of all medical devices other than cigarettes or 
smokeless tobacco. FDA is transferring the reporting requirements for 
importers of all devices other than cigarettes or smokeless tobacco 
from part 804 to part 803, Medical Device Reporting. Importers of 
medical devices will continue to be subject to the same reporting and 
recordkeeping requirements as they have been under parts 803 and 804, 
with the exception that, in accordance with FDAMA, importers of devices 
other than cigarettes or smokeless tobacco products are no longer 
required to submit annual certifications. They will continue to submit 
reports on Form 3500A. FDA will review and revise this form as 
necessary in the near future.
    2. Distributor recordkeeping requirements, which also remain in 
effect, are being transferred from part 804 to part 803, except for 
those requirements that apply to distributors of cigarettes or 
smokeless tobacco. The recordkeeping requirements for distributors of 
cigarettes or smokeless tobacco remain in part 804. No additional 
requirements for distributor recordkeeping are being added by these 
changes.
    3. In accordance with FDAMA, FDA is also amending part 803 to 
reflect the change from semiannual to annual reporting for device user 
facilities, to eliminate certification requirements for manufacturers 
of medical devices other than cigarettes or smokeless tobacco, and to 
limit the disclosability of device user facility identities.
    4. FDA is not changing or adding any requirements with respect to 
manufacturers or distributors of cigarettes or smokeless tobacco, as 
defined in part 897.

B. Specific Changes to Parts 803 and 804

    Reporting and recordkeeping requirements for distributors 
(including distributors who are importers) of cigarettes or smokeless 
tobacco, as defined in part 897, remain in part 804. Reporting and 
recordkeeping requirements for manufacturers of all medical devices, 
including manufacturers of cigarettes or smokeless tobacco, and 
importers of devices other than cigarettes or smokeless tobacco are 
contained in part 803. Recordkeeping requirements for distributors of 
products other than cigarettes or smokeless tobacco are also contained 
in part 803. These parts are amended as follows:
Changes to Part 803
    1. Section 803.1 is amended to reflect that the scope of the 
regulation now includes reporting requirements for importers, as well 
as manufacturers and device user facilities, and to clarify that 
distributors continue to be responsible for maintaining incident files.
    2. Section 803.3 is amended to reflect that importers continue to 
be responsible for reporting, by modifying definitions related to 
reporting so that importers are included.
    3. Section 803.9 is amended by removing paragraph (c)(3), which had 
required FDA to disclose the name of a device user facility making a 
report if the adverse event was required to be reported by a 
manufacturer or distributor. The removal of this paragraph corresponds 
to the elimination by FDAMA of section 519(b)(2)(C) of the act.
    4. Section 803.10 is amended to reflect that importers of medical 
devices remain responsible for reporting adverse device events, by 
transferring to this section the requirements that were previously 
codified under part 804. Furthermore, Sec. 803.10(a)(2) is amended to 
reflect that device user facilities are now responsible for submitting 
annual, not semiannual reports. Section 803.10(c)(5) is amended to 
correspond with the revocation of section 519(d) of the act, which had 
required annual certification of the number of medical devices report 
(MDR) reports filed during the preceding year. Revised 
Sec. 803.10(c)(5) reflects that manufacturers of cigarettes or 
smokeless tobacco continue to be responsible for complying with the 
annual certification requirements described in Sec. 803.57.
    5. Sections 803.11, 803.17, 803.19, 803.20, 803.22, and 803.56 are 
amended to reflect that importers continue to be subject to the MDR 
reporting requirements. Section 803.18 is amended to add ``importers'' 
to reflect that importers continue to be responsible for maintaining 
MDR event files, and to clarify that distributors of medical devices 
also continue to be responsible for establishing device complaint files 
and maintaining device incident records.
    6. Section 803.12 is amended to reflect the change from 
``semiannual'' to ``annual'' reports, and the continued inclusion of 
importers as reporting entities. Section 803.33 is amended to reflect 
that device user facilities are required to submit annual, not 
semiannual reports.
    7. A new subpart D, consisting of Secs. 803.40 and 803.43, has been 
added to reflect that importers of medical devices continue to be 
subject to the MDR reporting requirements. These sections represent the 
transfer of relevant provisions of part 804 (which now applies only to 
distributors, including those who are importers, of cigarettes or 
smokeless tobacco) into part 803. Importer reporting and recordkeeping 
requirements are not being changed by this transfer.
    8. Section 803.57 is amended to clarify that the section applies 
only to manufacturers of cigarettes or smokeless tobacco. This 
amendment reflects the revocation of section 519(d) of the act, which 
had required annual certification of the number of MDR reports filed 
during the preceding year, as it applied to manufacturers of all 
devices other than cigarettes or smokeless tobacco. This change also 
reflects the rule of construction in section 422 of FDAMA under which 
FDA's regulatory authority under the act relating to tobacco products 
shall be exercised under the act as in effect on the day before the 
date of enactment of FDAMA.

[[Page 26071]]

Changes to Part 804
    1. Section 804.1, the scope of part 804, Medical Device Distributor 
Reporting, is amended to reflect that this part now applies only to 
distributor reports of adverse events relating to contamination of 
cigarettes or smokeless tobacco products.
    2. Section 804.3 is amended to limit the definition of 
distributors, for the purposes of part 804, to distributors (including 
distributors who are importers) of cigarettes or smokeless tobacco 
products, and to clarify that adverse events that are reportable by 
distributors are only those related to contamination of cigarettes or 
smokeless tobacco.
    3. Section 804.25 is amended to clarify that adverse events that 
are reportable under this part are only those related to contamination 
of cigarettes or smokeless tobacco.

III. Rulemaking Action

    In the Federal Register of November 21, 1997, FDA described its 
procedures on when and how FDA will employ direct final rulemaking. FDA 
believes that this rule is appropriate for direct final rulemaking 
because FDA views this rule as a noncontroversial amendment and 
anticipates no significant adverse comments. Consistent with FDA's 
procedures on direct final rulemaking, FDA is publishing elsewhere in 
this issue of the Federal Register a companion proposed rule to amend 
existing parts 803 and 804. The companion proposed rule and the direct 
final rule are substantively identical. The companion proposed rule 
provides a procedural framework within which the rule may be finalized 
in the event the direct final rule is withdrawn because of a 
significant adverse comment. The comment period for the direct final 
rule runs concurrently with the companion proposed rule. Any comments 
to the companion proposed rule will be considered as comments regarding 
the direct final rule.
    FDA has provided a comment period on the direct final rule of July 
27, 1998. If the agency receives a significant adverse comment, FDA 
intends to withdraw this final rule by publication in the Federal 
Register within 30 days after the comment period ends. 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 
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 significant or adverse under this procedure. For example, a 
comment recommending an additional change to the rule may be considered 
a significant adverse comment if the comment demonstrates 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.
    If FDA withdraws the direct final rule, all comments received will 
be considered under the proposed rule in developing a final rule in 
accordance with usual Administrative Procedure Act notice-and-comment 
procedures.
    If FDA receives no significant adverse comment during the specified 
comment period, FDA intends to 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.

IV. 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.

V. Analysis of Impacts

    FDA has examined the impact of this direct final rule under 
Executive Order 12866 and 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 direct 
final rule is consistent with the regulatory philosophy and principles 
identified in the Executive Order. In addition, this direct final 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 rule codifies the elimination of reporting by 
distributors, other than distributors (including distributors who are 
importers) of cigarettes or smokeless tobacco, continues reporting by 
importers (including distributors who are importers), increases 
protection from disclosure of the identity of device user facilities 
that have submitted reports, reduces summary reporting by device user 
facilities from semiannual to annual, eliminates annual certification 
for manufacturers and distributors (including importers) of medical 
devices other than cigarettes or smokeless tobacco, and makes other 
nonsubstantive changes. The agency certifies that this final rule will 
not have a significant economic impact on a substantial number of small 
entities. This direct final 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.

VI. Paperwork Reduction Act of 1995

    This direct final 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 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 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

[[Page 26072]]

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 eliminated the 
reporting requirements for medical device distributors (but not for 
importers), as well as the certification requirements for medical 
device manufacturers and distributors. This section of FDAMA also 
modified the summary reporting requirements for user facilities to 
require annual, rather than semiannual, reporting, and increased 
confidentiality of user facility identities. 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 rule amends FDA's regulations in parts 803 and 804 to reflect 
the changes to medical device reporting made by FDAMA.
     This direct final rule eliminates reporting by distributors other 
than distributors of cigarettes or smokeless tobacco, continues 
reporting by importers, increases the protection from disclosure of the 
identity of device user facilities that have submitted reports, reduces 
summary reporting by device user facilities from semiannual to annual, 
eliminates annual certification for manufacturers and distributors 
(including importers) of medical devices other than cigarettes or 
smokeless tobacco, and makes other nonsubstantive changes.
    Description of Respondents: Businesses or other for profit 
organizations.
    FDA estimates the burden for this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden                                  
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                                                      No. of                                                    
         21 CFR Section               No. of       Responses per   Total Annual      Hours per      Total Hours 
                                    Respondents     Respondent       Responses       Response                   
----------------------------------------------------------------------------------------------------------------
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       
----------------------------------------------------------------------------------------------------------------


                                 Table 2.--Estimated Annual Recordkeeping Burden                                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
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               2           1,365       
804.35                              1,365               1           1,365               1.5         2,047       
TOTAL                             ..............  ..............  ..............  ..............   67,058       
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.   

    The burdens under this direct final rule are explained as follows:
Reporting Requirements
    Prior to the program change reflected 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 rule, 
Sec. 803.19 is 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 are no longer required to submit MDR reports under this 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 reflected in this rule, Sec. 803.33 
required medical device user facilities to submit summary reports 
semiannually. Under this rule, user facilities are 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 rule the reporting requirement for importers of medical 
devices other than cigarettes or smokeless tobacco previously codified 
under Sec. 804.25 is being transferred to 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 have been retained in part 804.
    Prior to the program change reflected in this rule, Sec. 803.56 
required

[[Page 26073]]

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 importers) were required to 
submit supplemental information under Sec. 804.32. Under this rule, 
Sec. 803.56 is 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 are no longer required to submit MDR reports (and thus 
supplemental reports as well) under this 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 reflected 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 rule, Sec. 803.57 is 
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 have been retained in Sec. 804.30.
    Prior to the program change reflected in this rule, Sec. 804.25 
required medical device distributors (including importers) to report 
adverse device events. Under this 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 have been 
transferred to part 803. Section 804.25 now requires 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 of 
cigarettes or smokeless tobacco submitted in any given year.
    Prior to the program change reflected 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 importers) of 
medical devices other than cigarettes or smokeless tobacco. Section 
804.30 now requires 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 shall 
submit one certification annually.
    Prior to the program change reflected 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 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 have been transferred to part 803. 
Section 804.32 now requires 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 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 Sec. 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 reflected 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 are 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 now allows 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.
 Recordkeeping Requirements
    Prior to the program change reflected 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 rule, the 
requirements for establishing written MDR procedures for importers of 
medical devices other than cigarettes or smokeless tobacco have been 
transferred to Sec. 803.17, and the requirements for distributors 
(including importers) of cigarettes or smokeless tobacco are 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 reflected 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 
rule, Sec. 803.18 is 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 have been retained in 
Sec. 804.35.
    Prior to the program change reflected in this rule, Sec. 804.34 
required distributors (including importers) of all medical devices to 
establish written

[[Page 26074]]

procedures for employee education, complaint processing, and 
documentation of information related to MDR reports. Under this rule, 
distributors of medical devices other than cigarettes or smokeless 
tobacco are no longer required to submit MDR reports. Accordingly, they 
are no longer subject to the requirement to establish and maintain 
written MDR procedures although distributors are required to establish 
device complaint files in accordance with 21 CFR 820.198. Under this 
rule, the requirement for establishing written MDR procedures for 
importers of medical devices other than cigarettes or smokeless tobacco 
is transferred to Sec. 803.17, and the requirements for distributors 
(including distributors who are importers) of cigarettes or smokeless 
tobacco are 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 reflected in this rule, Sec. 804.35 
required distributors (including importers) to establish and maintain 
MDR event files. Under this rule, the recordkeeping burdens for 
distributors (including importers) of medical devices other than 
cigarettes or smokeless tobacco have been transferred to Sec. 803.18. 
Recordkeeping requirements for distributors (including distributors who 
are importers) of cigarettes or smokeless tobacco are retained in 
Sec. 804.35.
    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 direct final rule by July 
13, 1998, to the Dockets Management Branch (address above).
    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 current valid OMB 
control number.

VII. Request for Comments

    Interested persons may, on or before July 27, 1998, submit to the 
Docket Management Branch (address above) written comments regarding 
this rule. The comment period runs concurrently with the comment period 
for the companion proposed 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 brackets in the heading 
of this document. 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 companion proposed rule 
and this direct final rule. In the event the direct final rule is 
withdrawn, all comments received regarding the companion proposed rule 
and this direct final rule will be considered comments on the 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, 21 CFR 
parts 803 and 804 are 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

[[Page 26075]]

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.
    (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.
* * * * *

[[Page 26076]]

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 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.


[[Page 26077]]


    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, 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. 98-12614 Filed 5-11-98; 8:45 am]
BILLING CODE 4160-01-F