[Federal Register Volume 61, Number 148 (Wednesday, July 31, 1996)]
[Rules and Regulations]
[Pages 39868-39869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19411]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 803
RIN 0910-AA09
Docket No. [91N-0295]
Medical Devices; Medical Device Reporting; Baseline Reports; Stay
of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: In response to numerous requests for the Food and Drug
Administration (FDA) to further consider comments concerning
manufacturer medical device reporting (MDR) baseline reporting
requirements, FDA is staying the effective date of certain portions of
the baseline reporting requirements. The stay of these requirements
will allow FDA to further evaluate the issues raised by the comments
and to determine whether the requirements should be revised.
EFFECTIVE DATE: July 31, 1996.
FOR FURTHER INFORMATION CONTACT: Earl W. Robinson, Center for Devices
and Radiological Health (HFZ-530), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-594-2735.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 11, 1995
(60 FR 63578) FDA published a final rule amending part 803 (21 CFR part
803) requiring medical device manufacturers to submit certain reports
relating to adverse events (hereinafter referred to as the December
1995 final rule). The effective date of this rule was initially to be
April 11, 1996. However, on April 11, 1996 (61 FR 16043), FDA extended
the effective date to July 31, 1996.
Under the December 1995 final rule, manufacturers were required to
submit individual reports of adverse events on a monthly basis, as well
as annual baseline reports. Section 803.55 requires that the baseline
reports include information specifically identifying a device for which
an adverse event has been submitted, the number of devices manufactured
and distributed in the last 12 months, an estimate of the number of
devices in current use, and a brief description of any methods used to
estimate the number of devices distributed and in current use. Among
the primary purposes of these baseline data requirements is to provide
information on population exposure to a particular device which
together with the number of adverse event reports would provide
relevant information about the rate of reported events for a particular
device to aid the agency in evaluating an adverse event's significance.
For example, information concerning the number of devices manufactured,
distributed or in current use (hereinafter referred to as denominator
data) is intended to enable the agency to determine how many people are
exposed to potential risk from a device and whether 100 malfunction
reports for a particular device represents a .001 percent (100 of
10,000,000) reported failure or a 10 (100 of 1,000) percent reported
failure.
After issuing the December 11, 1995, final rule, FDA received
numerous requests for reconsideration of the baseline reporting
requirements. Specifically, industry objected that the requirements for
denominator data were burdensome. These comments led FDA to meet with
the Health Industry Manufacturers Association (HIMA) and several other
industry representatives on April 19, May 23, June 13, and July 1,
1996. During these meetings and FDA internal meetings, issues
concerning industry burdens and FDA evaluation of data were put forth
that had previously not been considered.
Specifically, issues were raised about the ability to derive
accurate information about adverse event rates of devices by the
denominator data. The agency needs additional time to consider and
better understand methods used to derive denominator estimates. FDA
believes that a pilot program to analyze how certain variables affect
the denominator data and how that data is used would allow the agency
to implement denominator data requirements to evaluate the rate of and
relative impact of adverse events more accurately. FDA intends to
evaluate these issues further, and with the cooperation of industry in
the near future, to implement such a pilot program, and subsequently to
analyze these factors. Assuming that there is sufficient participation
in the program, FDA anticipates that the completion of a successful
pilot program would take from 12 to 18 months.
Because of the need for further analysis of variables affecting
denominator data, FDA believes that baseline denominator data
requirements should be stayed. The agency believes a pilot program may
allow FDA to analyze the best possible means to obtain denominator
data. At the completion of the pilot program, or a determination that
because of inadequate participation, the pilot program is not feasible,
FDA will either lift the stay of the December 1995 final rule baseline
denominator reporting requirements, retain the stay, or proceed to
revise these requirements.
The Administrative Procedure Act (Pub. L. 79-404) and FDA
regulations provide that the agency may issue a regulation without
notice and comment procedures when the agency for good cause finds (and
incorporates the finding and a brief statement of reasons thereof in
the rules issued) that notice and public comment procedures thereon are
impracticable, unnecessary, or contrary to the public interest (5
U.S.C. 553(b)(8); Sec. 10.40(e)(1)).) FDA finds that there is good
cause for dispensing with notice and comment procedures to stay the
effective date of the manufacturer baseline reporting requirements for
denominator data (Sec. 803.55((b)(9) and (10)) (corresponding with data
elements 15 and 16 on FDA Form 3417) because such notice and comment
procedures are impracticable and contrary to the public interest.
[[Page 39869]]
Notice and comment rulemaking on the postponement of baseline
reporting denominator data is impracticable. FDA was not aware of
significant issues relating to these requirements until after
publication of the December 1995 final rule. Since that time, FDA has
had numerous meetings with industry representatives and internal
meetings to decide the best approach to resolve issues concerning the
rule. The last such meeting occurred on July 1, 1996. Without the
issuance of a stay under good cause procedures, the baseline
denominator information reporting requirements would become effective
on July 31, 1996.
In addition, notice and comment rulemaking on the stay of the
baseline denominator reporting data would be contrary to the public
interest. Because there is not enough time to allow notice and comment
on the issue of staying the effective date before it occurs, the
baseline denominator data requirements would go into effect on July 31,
1996. Consequently, industry would be required to implement additional
procedures that may, after further evaluation, soon be replaced with
different procedures leading to more accurate information. This may
lead to unnecessary confusion and expense.
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: Secs. 502, 510, 519, 520, 701, 704 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 371, 374).
2. In the revision of part 803 which was published at 60 FR 63578
(December 11, 1995), the effective date of which was extended until
July 31, 1996, at 61 FR 16043 (April 11, 1996), the provisions of
Sec. 803.55(b)(9) and (10) are stayed until further notice.
Dated: July 25, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-19411 Filed 7-30-96; 8:45 am]
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