[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]


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.


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 
    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:


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

    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]