Skip to Content

Notice

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.

DATES:

Submit either electronic or written comments on the collection of information by August 25, 2014.

ADDRESSES:

Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program—(OMB Control Number 0910-0700)—Extension

Under section 228 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), as amended by section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(7)), the owner or operator of an establishment may submit an audit report that assesses conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice.

The “Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program” describes how FDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are implementing this provision of the law and providing public notice as required. The proposed collections of information are necessary to satisfy the previously mentioned statutory requirements for implementing this voluntary submission program. The collected information is used for setting risk-based inspectional priorities.

The “Guidance for Industry, Third Parties, and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program” describes how FDA's Center for Devices and Start Printed Page 36319Radiological Health and Center for Biologics Evaluation and Research are implementing this provision of the law and providing public notice as required. The proposed collections of information are necessary to satisfy the previously mentioned statutory requirements for implementing this voluntary submission program.

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

Table 1—Estimated Annual Reporting Burden 1

ActivityNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hoursTotal operating and maintenance costs
(One time only burden) First year, electronic setup and verification certificate 11,70011,7002 4271,400$51,000
(Recurring burden) Audit report submission1,70011,70035,10051,000
1 There are no capital costs associated with this information collection.
2 Respondent may already have a valid WebTrader account established for other FDA electronic submissions.

Based on FDA's experience with the founding regulatory members of the Global Harmonization Task Force (GHTF), FDA expects that the vast majority of manufacturers who will participate in the Voluntary Audit Report Submission Program will be manufacturers who are certified by Health Canada under ISO 13485:2003.

In addition, FDA only expects firms that do not have major deficiencies or observations in their ISO 13485:2003 audits to be willing to submit their audit reports to FDA under the Voluntary Audit Report Submission Program. FDA analyzed its inspection data from Fiscal Year (FY) 2013 (October 1, 2012 to October 1, 2013) and determined that the total number of inspections finalized in FY 2013 for medical devices was 2,404. The breakdown for the 2,404 compliance decisions is as follows:

Table 2—Compliance Decisions FY 2013

Compliance decisionNumberApproximate percentage
Official Action Indicated1697
Voluntary Action Indicated90238
No Action Indicated1,08345
Pending Final Decision24910

Because FDA only expects firms who do not have major deficiencies or observations to be willing to submit their audit reports to FDA under the Voluntary Audit Report Submission Program, FDA only expects to receive audit reports that would have been classified by FDA as No Action Indicated (NAI).

Assuming that the percentage breakdown of compliance decisions for all inspections conducted in FY 2013 can be extrapolated and applied to audits of manufacturers certified under ISO 13485:2003 by Health Canada, FDA can estimate the number of Canadian establishments that would have had an inspection classified as an NAI. Because 45 percent of all compliance decisions resulted in an NAI decision, FDA estimates that 1,546 of the facilities certified under ISO 13485:2003 by Health Canada (45 percent of the total 3,436 facilities) would have had an inspection classified as an NAI.

Because FDA expects that the vast majority of manufacturers who will participate in the Voluntary Audit Report Submission Program will be manufacturers certified by Health Canada under ISO 13485:2003, FDA expects the number of reports to be submitted from manufacturers certified by regulatory systems established by other founding GHTF members to be minimal. For purposes of calculating the reporting burden, FDA estimates that approximately 10 percent of total audit reports submitted under this program will be from these other manufacturers. Because 90 percent of the audit reports are expected to be submitted by manufacturers certified by Health Canada (approximately 1,500 audit reports), the total number of audit reports FDA expects to receive in a year is approximately 1,700 audit reports.

FDA estimates from past experience with the Electronic Submission Gateway system, WebTrader, that the first year to set up the account and to receive the verification certificate takes approximately 40 hours. This burden may be minimized if the respondent already has an established account in WebTrader for other electronic submissions to FDA, but FDA is assuming that all respondents to this new pilot program will be setting up a WebTrader account for the first time in the first year. For subsequent years, the burden hours are estimated at 1 hour to renew the yearly required verification certification.

FDA further estimates that the gathering, scanning, and submission of the audit reports, certificates, and related correspondence would take approximately 2 hours utilizing the eSubmitter system.

Therefore, the first year will include 40 hours for the WebTrader system plus 2 hours for the eSubmitter submission process, resulting in 42 hours per response for the first year. For subsequent years, it is estimated that only 1 hour will be necessary for the WebTrader system plus the 2 hours for the eSubmitter submission process, resulting in 3 hours per response each year thereafter.

There are operating and maintenance costs associated with this information collection. The costs are $30 per year to establish and maintain the Electronic Submission Gateway verification certificate.

This guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are Start Printed Page 36320subject to review by OMB under the PRA. The collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073, and the collections of information for the Inspection by Accredited Persons Program have been approved under OMB control number 0910-0569.

Start Signature

Dated: June 20, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2014-14924 Filed 6-25-14; 8:45 am]

BILLING CODE 4164-01-P