[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Notices]
[Pages 59775-59776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28664]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0260]
Agency Information Collection Activities; Submission for OMB
review; Comment Request; Medical Devices; Recall Authority
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments on the information collection by
December 3, 1999.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20501, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Devices; Recall Authority--21 CFR Part 810
Section 518(e) (21 U.S.C. 360h) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 321 et seq.) provides that if FDA
finds that there is a reasonable probability that a device intended for
human use would cause serious adverse health consequences or death, FDA
shall issue an order requiring the appropriate person to immediately
cease distribution of such device, immediately notify health
professionals and device user facilities of the order, and instruct
such professionals and facilities to cease use of the device. Under
this statutory authority, FDA issued regulations under part 810 (21 CFR
part 810).
The regulation in Sec. 810.10(d) provides that FDA may require the
person named in the cease distribution and notification order to submit
certain information to the agency. Section 810.11(a) requires that a
request for a regulatory hearing regarding the cease distribution and
notification order must be submitted in writing to FDA. In lieu of a
written request for a regulatory hearing, the person named in the cease
distribution and notification order may submit a written request asking
that the order be modified or vacated as provided in Sec. 810.12(a).
Under Sec. 810.12(b), a written request for review of a cease
distribution and notification order must identify each ground upon
which the requestor relies in asking that the order be modified or
vacated and address an appropriate cease distribution and notification
strategy. A written request must also address whether the order should
be amended to require a recall of the device that was the subject of
the order.
Section 810.14 states that the person named in the cease
distribution and notification order or a mandatory recall order must
develop a strategy for complying with the order that is appropriate for
the individual circumstances and submit the strategy to the agency for
review. Section 810.15(a) requires that the person named in the cease
distribution and notification order or a mandatory recall order must
promptly notify each health professional, user facility, consignee, or
individual of the order, and Sec. 810.15(b) through (c) prescribes the
contents and implementation of such notification. Section 810.15(d)
requires the person named in the order to ensure that followup
communications are sent to all who fail to respond to the initial
communications. Under Sec. 810.15(e), recipients of such letters must
follow instructions in the letter and notify consignees of the order.
Section 810.16 requires that the person named in a cease distribution
and notification order or a mandatory recall order submit periodic
status reports to FDA to enable the agency to assess the person's
progress in complying with the order. The frequency of such reports and
the agency official to whom such reports must be submitted will be
specified in the order. Lastly, Sec. 810.17 provides that the person
named in a cease distribution and notification order or a mandatory
recall order may request termination of the order by submitting a
written request to FDA. The person submitting a request must certify
that he or she has complied in full with all the requirements of the
order and must include a copy of the most current status report
submitted to the agency.
The information collected under the recall authority will be used
by FDA to ensure that all devices entering the market are safe and
effective, to learn quickly about serious problems with medical
devices, and to remove dangerous and defective devices from the market.
In the preamble to the final rule (61 FR 59004 at 59018, November
20, 1996), hereinafter referred to as the November 1996 final rule, the
agency requested comments on the information collection provisions of
the new regulation. The 60-day comment period closed January 21, 1997.
The agency received two comments. The comments stated that: (1) The
information collection requirements in this regulation are redundant
and time and resource consuming, and (2) FDA should provide for the use
of electronic media for complying with this rule.
FDA disagrees with the comment that the information collection
requirements for the medical device recall authority are redundant and
time and resource consuming. Almost all recalls are carried out under
the voluntary recall procedures in part 7 (21 CFR part 7). As discussed
in the November 1996 final rule, for cease distribution and
notification orders and recall orders, FDA interprets the standard in
Secs. 810.10(a) and 810.13 to match closely to the elements of a class
I voluntary recall under part 7, subpart C, for which the agency has a
long record of experiences. FDA will initiate a mandatory recall under
section 518(e) of the act when FDA finds that there is a reasonable
probability that a device would cause serious, adverse health
consequences or death. A firm may initiate a voluntary recall of a
violative device without FDA intervention;
[[Page 59776]]
however, if FDA determines that such a voluntary recall is not
effective in remedying a violation and there remains a reasonable
probability that the violative device would cause serious adverse
health consequences or death, FDA will invoke the medical device recall
authority in addition to the voluntary efforts that the manufacturer
has already undertaken. FDA will not order a mandatory recall if a
voluntary recall has been effective in addressing the problems.
FDA believes that the November 1996 final rule provides sufficient
flexibility so as to minimize the burden on those required to take
action consistent with the determination that the device presents a
risk of serious adverse health consequences or death. FDA expects that
at most one or two recalls per year would be ordered that would not
have occurred without this regulation.
In response to the comment regarding the use of electronic media
for complying with these provisions, the regulation for electronic
records and electronic signatures became effective March 20, 1997. Part
11 (21 CFR part 11) sets forth the criteria under which FDA will accept
documents and signatures in electronic form in lieu of paper.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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810.10(d) 2 1 2 8 16
810.11(a) 1 1 1 8 8
810.12(a) and (b) 1 1 1 8 8
810.14 2 1 2 16 32
810.15(a) through (d) 2 1 2 16 32
810.15(e) 10 1 1 1 10
810.16 2 12 24 40 960
810.17 2 1 2 8 16
Total 1,082
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\1\ There are no operating and maintenance or capital costs associated with this collection of information.
FDA developed these estimates based on its experience with the
number of voluntary recalls received in the last 3 years and other
similar procedures.
Dated: October 27, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-28664 Filed 11-2-99; 8:45 am]
BILLING CODE 4160-01-F
