Agency Information Collection Activities; Submission for OMB review; Comment Request; Medical Devices; Recall Authority

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