[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
[Docket No. 98N-0170]
Medical Devices; Medical Device Reporting Regulations; Technical
Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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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.
SUPPLEMENTARY INFORMATION:
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
publication.
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
text.
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
following:
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
section.
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
million.
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
required.
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:
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 803.3 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
recur.
* * * * *
[[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
manufacturer.
(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
requirements.
(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
effects.
* * * * *
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]
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