Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority

Summary:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Table of Figures

Dates:

Fax written comments on the collection of information by March 12, 2012.

Addresses:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0432. Also include the FDA docket number found in brackets in the heading of this document.

For further information contact:

Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@fda.hhs.gov.

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 Device Recall Authority—21 CFR Part 810 (OMB Control Number 0910-0432)—Extension

This collection of information implements section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and part 810 (21 CFR part 810), medical device recall authority provisions. Section 518(e) of the FD&C Act provides FDA with the authority to issue an order requiring an appropriate person, including manufacturers, importers, distributors, and retailers of a device, if FDA finds that there is reasonable probability that the device intended for human use would cause serious adverse health consequences or death, to: (1) Immediately cease distribution of such device, (2) immediately notify health professionals and device-user facilities of the order, and (3) instruct such professionals and facilities to cease use of such device.

Further, the provisions under section 518(e) of the FD&C Act set out the following three-step procedure for issuance of a mandatory device recall order:

1. If there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, FDA may issue a cease distribution and notification order requiring the appropriate person to immediately:

• Cease distribution of the device,

• Notify health professionals and device user facilities of the order, and

• Instruct those professionals and facilities to cease use of the device;

2. FDA will provide the person named in the cease distribution and notification order with the opportunity for an informal hearing on whether the order should be modified, vacated, or amended to require a mandatory recall of the device; and

3. After providing the opportunity for an informal hearing, FDA may issue a mandatory recall order if the Agency determines that such an order is necessary.

The information collected under the recall authority provisions will be used by FDA to do the following: (1) Ensure that all devices entering the market are safe and effective, (2) accurately and immediately detect serious problems with medical devices, and (3) remove dangerous and defective devices from the market.

In the Federal Register of November 16, 2011 (76 FR 71041), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden1
21 CFR SectionNumber ofrespondents Number ofresponses per respondent Total annualresponses Averageburden per response Total hours
1There are no capital costs or operating and maintenance costs associated with this collection of information.
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), (b), and (c) 2 1 2 12 24
810.15(d) 2 1 2 4 8
810.15(e) 10 1 10 1 10
810.16(a) and (b) 2 12 24 40 960
810.17(a) 2 1 2 8 16
Total Hours 1,082
Table 2—Estimated Annual Recordkeeping Burden1
21 CFR SectionNumber ofrecordkeepers Number ofrecords per recordkeeper Total annualrecords Averageburden per recordkeeping Total hours
1There are no capital costs or operating and maintenance costs associated with this collection of information.
810.15(b) 2 1 1 8 8

The burden estimates for tables 1 and 2 of this document are based on FDA's experience with voluntary recalls under part 810 of the regulations. FDA expects no more than two mandatory recalls per year, as most recalls are done voluntarily. Since the last time this collection of information was submitted to OMB for renewal/approval, there has been one mandatory recall.

Dated: February 6, 2012. Leslie Kux,

Acting Assistant Commissioner for Policy.

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