[Federal Register Volume 75, Number 97 (Thursday, May 20, 2010)]
[Notices]
[Pages 28257-28260]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0226]


Draft Guidance for Industry, Third Parties and Food and Drug 
Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit 
Report Submission Program; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Medical Device ISO 
13485:2003 Voluntary Audit Report Submission Program.'' This draft 
guidance is intended to provide information on the implementation of a 
section of the Food and Drug Administration Amendments Act of 2007 
(FDAAA), which amends a section of the Federal Food, Drug, and Cosmetic 
Act (the act). This guidance document describes how FDA's Center for 
Devices and Radiological Health (CDRH) and Center for Biologics 
Evaluation and Research (CBER) are implementing this provision of the 
law. This draft guidance is not final nor is it in effect at this time.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit

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written or electronic comments on the draft guidance by August 18, 
2010. Submit written or electronic comments on the collection of 
information July 19, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Medical Device ISO 13485:2003 Voluntary 
Audit Report Submission Program'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (DSMICA), Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Room 4613, Silver Spring, MD 20993 
or to the Office of Communications, Outreach and Development (HFM-40), 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. The draft guidance may also be obtained by mail by calling CBER 
at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kimberly A. Trautman, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Room 3422, Silver Spring, MD 20993, 301-
796-5515, or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance is intended to provide information on the 
implementation of section 228 of FDAAA, which amends section 704(g)(7) 
of the act (21 U.S.C. 374(g)(7)). Under this draft guidance, device 
manufacturers whose establishment has been audited under one of the 
regulatory systems implemented by the Global Harmonization Task Force 
(GHTF) founding members\1\ using ISO 13485:2003 ``Medical devices--
Quality management systems--Requirements for regulatory purposes,'' may 
voluntarily submit the resulting audit report to FDA. If, based on that 
report, FDA determines there is minimal probability--in light of the 
relationship between the quality system deficiencies observed and the 
particular device and manufacturing processes involved--that the 
establishment will produce nonconforming and/or defective finished 
devices, then FDA intends to use the audit results as part of its risk 
assessment to determine whether that establishment can be removed from 
FDA's routine work plan for 1 year. The medical device ISO 13485:2003 
Voluntary Audit Report Submission Program outlined in this draft 
guidance is another way in which FDA may leverage audits performed by 
other GHTF regulators and accredited third parties in order to assist 
the agency in setting risk-based inspectional priorities.
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    \1\ The GHTF founding members auditing systems include the 
Canadian Medical Devices Conformity Assessment System; the European 
Union Notified Body accreditation system; the Therapeutics Goods 
Administration of Australia Inspectorate; and the Japanese Medical 
Device Ministry of Health, Labour and Welfare system.
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    This notice of availability and draft guidance satisfy the public 
notice requirement of section 704(g)(7)(F) of the act, which provides 
that FDA shall give public notice of the ISO standard(s) under which 
FDA accepts voluntary submissions of audit reports.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on ``Medical 
Device ISO 13485:2003 Voluntary Audit Report Submission Program.'' It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute 
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Draft Guidance for Industry, 
Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary 
Audit Report Submission Program'' you may either send an e-mail request 
to dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1705 to identify the guidance you are requesting.
    A search capability for all CDRH guidance documents is available at 
http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov or at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 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.
    Title: Draft Guidance for Industry, Third Parties and FDA Staff: 
Medical Device ISO 13485:2003 Voluntary Audit Report Submission 
Program.
    Description: Section 228 of the Food and Drug Administration 
Amendments Act of 2007 (FDAAA), amended section 704(g)(7) of the Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 374(g)(7)) to add the 
following provision:
    ``(F) For the purpose of setting risk-based inspectional 
priorities, the Secretary shall accept voluntary

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submissions of reports of audits assessing conformance with appropriate 
quality system standards set by the International Organization for 
Standardization (ISO) and identified by the Secretary in public notice. 
If the owner or operator of an establishment elects to submit audit 
reports under this subparagraph, the owner or operator shall submit all 
such audit reports with respect to the establishment during the 
preceding 2-year periods.''
    The ``Draft Guidance for Industry, Third Parties and FDA Staff: 
Medical Device ISO 13485:2003 Voluntary Audit Report Submission 
Program'' will describe how FDA's CDRH and CBER 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\
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                            No. of        Annual Frequency     Total Annual       Hours per
 Type of Respondent      Respondents        per Response        Responses         Response        Total Hours
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Domestic or foreign               1,600                  1              1,600               2              3,200
 device manufacturer
 whose establishment
 was audited under
 ISO 13485:2003
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on FDA's experience with the founding regulatory members of 
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.\2\ In 2008, approximately 2,650 manufacturers or 
manufacturing sites had been certified by Health Canada.
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    \2\ The majority of these manufacturers are also certified under 
ISO 13485:2003 by the European Union Notified Body accreditation 
system.
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    In addition, FDA only expects firms who 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) 2008 (October 1, 2007 to October 1, 2008) and determined that 
the total number of inspections finalized in FY2008 for medical devices 
was 1,965. The breakdown for the 1,965 compliance decisions is as 
follows:

                                     Table 2.--Compliance Decision Breakdown
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    Compliance Decision\1\                       Number                           Approximate Percentage
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Official Action Indicated                                           148                                       8%
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Voluntary Action Indicated                                          775                                      40%
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No Action Indicated                                               1,025                                      52%
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Pending Final Decision                                               17                                       1%
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\1\ June 15, 2006, Compliance Program 7382.845 Inspection of Medical Device Manufacturers Part V http://www.fda.gov/cdrh/comp/guidance/7382.845.html#p5p5.pdf.

    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 FY2008 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. Since 52 percent of 
all compliance decisions resulted in a NAI decision, FDA estimates that 
1,378 of the facilities certified under ISO 13485:2003 by Health Canada 
(52 percent of the total 2,650 facilities) would have had an inspection 
classified as an NAI. Since FDA only expects to receive audit reports 
that would have been classified by FDA as NAI, FDA expects 1,378, or 
approximately 1,400, audit reports to be submitted.
    Since 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. Since 90 percent of the audit reports are expected to be 
submitted by manufacturers certified by Health Canada (approximately 
1,400 audit reports as calculated previously in this document), then 
the total number of audit reports FDA expects to receive in a year is 
1,556, or approximately 1,600, audit reports.
    FDA further estimates that the gathering, scanning, and submission 
of the audit reports, certificates, and related correspondence would 
take approximately 2 hours.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. These collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 820 have been approved

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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.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: May 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-12098 Filed 5-19-10; 8:45 am]
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