[Federal Register Volume 66, Number 89 (Tuesday, May 8, 2001)]
[Rules and Regulations]
[Pages 23155-23157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11449]



Food and Drug Administration

21 CFR Part 803

[Docket No. 98N-0170]

Medical Devices; Medical Device Reporting Regulations; Technical 

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.


SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations governing Medical Device Reporting (MDR) requirements. When 
the final regulation was last amended, the regulation published with 
some errors and omissions that, if uncorrected, may prove to be 
misleading. This document corrects those errors.

DATES: This rule is effective May 8, 2001.

FOR FURTHER INFORMATION CONTACT: Susan E. Bounds, Center for Devices 
and Radiological Health (HFZ-500), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-2735.


I. Background

    In the Federal Register of January 26, 2000 (65 FR 4112), FDA 
published a final rule (the January 2000 rule) that amended its MDR 
regulations governing reporting by manufacturers, importers, 
distributors, and user facilities of adverse events related to medical 
devices. These amendments were made to implement revisions to the 
Federal Food, Drug, and Cosmetic Act (the act) under the Food and Drug 
Administration Modernization Act of 1997 (FDAMA). These regulations 
became effective March 27, 2000. Under certain provisions of FDAMA, 
reporting requirements for distributors were eliminated, but reporting 
requirements for importers, and requirements for distributors to keep 
records concerning adverse device events and make them available to FDA 
upon request continue to apply. To accommodate these changes, part 804 
(21 CFR part 804) was removed and language was integrated into part 803 
(21 CFR part 803) that reflected the retention of importer reporting 
requirements and recordkeeping requirements for distributors. Another 
change made by the January 2000 rule revised procedures to require 
annual, rather than semiannual, summary reporting by user facilities, 
and eliminated reporting certification requirements. As a result of 
these substantive amendments, many nonsubstantive changes were made to 
the organization of provisions in part 803. During preparation of the 
final rule for publication, however, a number of typographical and 
editorial errors occurred. In the subsequent months, FDA discovered 
other errors. The purpose of these amendments is to correct the errors 
identified in part 803. This document is published as a final rule with 
the effective date shown above. FDA has determined that this final rule 
has no substantive impact on the public. FDA, therefore, for good 
cause, finds under 5 U.S.C.553(b)(3)(B) and (d)(3) that notice and 
public comment are unnecessary and that this rule may take effect upon 

II. Need for Amendments

A. Incorporation of Importer Reporting Requirements Into Part 803

    Section 213 of FDAMA eliminated reporting requirements for 
distributors previously found at part 804. At the same time, reporting 
requirements for importers were retained and those previously 
referenced in part 804 were incorporated in part 803. Accordingly, the 
word ``distributor'' was removed from applicable paragraphs and the 
word ``importer'' was integrated into the text. During preparation of 
the final rule amending the regulations to incorporate importer 
requirements, however, the word ``importer'' was not properly 
integrated into Secs. 803.10, 803.20, 803.50, and 803.52. FDA is 
amending the regulations to correct this error.

B. Elimination of Reporting Certification and Modification of Semi-
Annual Reporting

    Section 213(a)(2) of FDAMA revoked section 519(d) of the act (21 
U.S.C. 360i(d)) resulting in the elimination of certification 
requirements. Section 213(c)(1)(A) revised section 519(b)(1)(C) of the 
act to require annual, rather than

[[Page 23156]]

semiannual, summary reporting by user facilities. During preparation of 
the final rule, however, an editorial error led to the omission in 
certain paragraphs of amended text that was written to remove 
references to certification requirements and change the word 
``semiannual'' to ``annual.'' Sections 803.10, 803.17, and 803.58 
contained these errors. FDA is amending the regulations to correct 
these errors.

C. Organization of Paragraphs

    The integration of importer reporting requirements and the removal 
of certification references required substantial reorganization of part 
803. This reorganization included the need to redesignate certain 
paragraphs and correct references to those paragraphs throughout the 
1. Definition of Device User Facility, MDR Reportable Event (or 
reportable event), and Work Day (Sec. 803.3(f), (r)(2)(ii), and (ee))
    Modifications to Sec. 803.3 require that paragraphs (m) through 
(ee) be redesignated as paragraphs (n) through (ff) to address the 
     At paragraph (f), the definition of a ``device user 
facility'' states that a ``physician's office'' is later defined in 
paragraph ``(w)'' of this section. In fact, the definition of 
``physician's office'' is found later at paragraph ``(x)'' of this 
     A further error occurred when redesignating the definition 
of an ``MDR reportable event (or reportable event)'' as paragraph 
(r)(2)(ii). In this instance, the words ``or contribute'' were 
inadvertently omitted after the words ``would be likely to cause,'' in 
the definition text.
     Finally, Sec. 803.3 contains two paragraphs ``(ee)'' 
because the definition of ``work day'' was not redesignated as 
paragraph ``(ff).''
FDA is amending the regulations to correct these errors.
2. General Description of Reports Required From User Facilities, 
Importers, and Manufacturers (Sec. 803.10(b))
    Previously, Sec. 803.10(b) was reserved. As amended by the January 
2000 rule, Sec. 803.10(b) was revised to include reporting requirements 
for importers. During preparation of the January 2000 rule, the amended 
text incorporated in this section was not organized in the same manner 
as Sec. 803.10(a) and (c). FDA is amending the regulations to correct 
this error.
3. Foreign Manufacturers (Sec. 803.58(b)(4), (b)(5), and (b)(6))
    The elimination of certification requirements by manufacturers 
resulted in the removal of  Sec. 803.58(b)(3); therefore, paragraphs 
(b)(4), (b)(5), and (b)(6) were to be redesignated accordingly. FDA is 
amending the regulations to correct this error.
4. Exemptions, Variances, and Alternative Reporting Requirements 
(Sec. 803.19)
    Independent of the errors in part 803 that resulted from the 
January 2000 rule, FDA discovered an obsolete reference in Sec.  
803.19(a)(2). In this instance, the text of Sec.  803.19(a)(2) 
references part 813, which was removed by a final rule published in the 
Federal Register on January 29, 1997 (62 FR 4164). FDA is amending the 
regulations to correct this error.

III. Environmental Impact

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

IV. Analysis of Impacts

    FDA has examined the impacts of the 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 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 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 final rule is consistent 
with the regulatory philosophy and principles identified in the 
Executive Order. In addition, the 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 agency certifies that this final rule will not 
have a significant negative economic impact on a substantial number of 
small entities. Section 202(a) of the Unfunded Mandates Reform Act of 
1995 (Public Law 104-4) requires that agencies prepare a written 
statement of anticipated costs and benefits before proposing any rule 
that may result in an expenditure by State, local, and tribal 
governments, in the aggregate, or by the private sector, of $100 
million in any 1 year (adjusted annually for inflation). The Unfunded 
Mandates Reform Act of 1995 does not require FDA to prepare a statement 
of costs and benefits for the final rule, because the final rule is not 
expected to result in any 1-year expenditure that would exceed $100 

V. Paperwork Reduction Act of 1995

    FDA has determined that this final rule contains no additional 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 

List of Subjects in 21 CFR Part 803

    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 part 
803 is amended as follows:


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

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
    2. Section 803.3 is amended by revising paragraphs (f) and 
(r)(2)(ii) and by redesignating the second paragraph (ee) as paragraph 
(ff) to read as follows:

Sec. 803.3  Definitions.

* * * * *
    (f) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, outpatient diagnostic facility, or outpatient 
treatment facility as defined in paragraphs (b), (l), (t), (u), and 
(v), respectively, of this section, which is not a ``physician's 
office,'' as defined in paragraph (x) of this section. School nurse 
offices and employee health units are not device user facilities.
* * * * *
    (r)  *  *  *
    (2)  *  *  *
    (ii) Has malfunctioned and that the device or a similar device 
marketed by the manufacturer or importer would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
* * * * *

[[Page 23157]]

    3. Section 803.10 is amended by revising paragraph (b) and by 
removing paragraph (c)(5) to read as follows:

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

* * * * *
    (b) Device importers. Importers must submit the following reports, 
which are described more fully in subpart D of this part.
    (1) Importers must submit MDR reports of individual adverse events 
within 30 days after the importer becomes aware of an MDR reportable 
event as described in Secs.  803.40 and 803.42.
    (i) Importers must submit reports of device-related deaths or 
serious injuries to FDA and to the manufacturer.
    (ii) Importers must submit reports of malfunctions to the 
    (2) [Reserved]
* * * * *
    4. Section 803.17 is amended by revising paragraph (b)(3) to read 
as follows:

Sec.  803.17  Written MDR procedures.

* * * * *
    (b)  *  *  *
    (3) Any information that was evaluated for the purpose of preparing 
the submission of annual reports; and
* * * * *
    5. Section 803.19 is amended by revising paragraph (a)(2) to read 
as follows:

Sec.  803.19  Exemptions, variances, and alternative reporting 

    (a)  *  *  *
    (2) An individual who manufactures devices intended for use in 
humans solely for such person's use in research or teaching and not for 
sale, including any person who is subject to alternative reporting 
requirements under the investigational device exemption regulations, 
part 812 of this chapter, which require reporting of all adverse device 
* * * * *
    6. Section 803.20 is amended by revising the introductory text of 
paragraph (a), and paragraphs (a)(2) and (c)(1) to read as follows:

Sec.  803.20  How to report.

    (a) Description of form. There are two versions of the MEDWATCH 
form for individual reports of adverse events. FDA Form 3500 is 
available for use by health professionals and consumers for the 
submission of voluntary reports regarding FDA-regulated products. FDA 
Form 3500A is the mandatory reporting form to be used for submitting 
reports by user facilities, importers, and manufacturers of FDA-
regulated products. The form has some sections that must be completed 
by all reporters and other sections that must be completed only by the 
user facility, importer, or manufacturer.
* * * * *
    (2) The back part of the form contains sections to be completed by 
user facilities, importers, and manufacturers. User facilities and 
importers must complete section F; device manufacturers must complete 
sections G and H. Manufacturers are not required to recopy information 
submitted to them on a Form 3500A unless the information is being 
copied onto an electronic medium. If the manufacturer corrects or 
supplies information missing from the other reporter's 3500A form, it 
should attach a copy of that form to the manufacturer's report form. If 
the information from the other reporter's 3500A form is complete and 
correct, the manufacturer can fill in the remaining information on the 
same form.
* * * * *
    (c) Information that reasonably suggests a reportable event 
occurred. (1) Information that reasonably suggests that a device has or 
may have caused or contributed to an MDR reportable event (i.e., death, 
serious injury, and, for manufacturers and importers, a malfunction 
that would be likely to cause or contribute to a death or serious 
injury if the malfunction were to recur) includes any information, such 
as professional, scientific or medical facts and observations or 
opinions, that would reasonably suggest that a device has caused or may 
have caused or contributed to a reportable event.
* * * * *
    7. Section 803.50 is amended by revising paragraphs (b)(1)(i) and 
(b)(2) to read as follows:

Sec.  803.50  Individual adverse event reports; manufacturers.

* * * * *
    (b)  *  *  *
    (1)  *  *  *
    (i) Any information that can be obtained by contacting a user 
facility, importer, or other initial reporter;
* * * * *
    (2) Manufacturers are responsible for obtaining and providing FDA 
with information that is incomplete or missing from reports submitted 
by user facilities, importers, and other initial reporters. 
Manufacturers are also responsible for conducting an investigation of 
each event and evaluating the cause of the event. If a manufacturer 
cannot provide complete information on an MDR report, it must provide a 
statement explaining why such information was incomplete and the steps 
taken to obtain the information. Any required information not available 
at the time of the report, which is obtained after the initial filing, 
must be provided by the manufacturer in a supplemental report under 
Sec.  803.56.
    8. Section 803.52 is amended by revising paragraphs (d)(1), 
(f)(11)(i), and (f)(11)(ii) to read as follows:

Sec.  803.52  Individual adverse event report data elements.

* * * * *
    (d)  *  *  *
    (1) Name, address, and phone number of the reporter who initially 
provided information to the user facility, manufacturer, or importer;
* * * * *
    (f)  *  *  *
    (11)  *  *  *
    (i) Any information missing on the user facility report or importer 
report, including missing event codes, or information corrected on such 
forms after manufacturer verification;
    (ii) For each event code provided by the user facility under 
Sec. 803.32(e)(10) or the importer under Sec.  803.42(e)(10), a 
statement of whether the type of event represented by the code is 
addressed in the device labeling; and
* * * * *

Sec.  803.58  [Amended]

    9. Section 803.58 Foreign manufacturers is amended by removing 
paragraph (b)(3) and by redesignating paragraphs (b)(4), (b)(5), and 
(b)(6) as paragraphs (b)(3), (b)(4), and (b)(5), respectively.

    Dated: April 18, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-11449 Filed 5-7-01; 8:45 am]