
[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Notices]
[Pages 16036-16038]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6503]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

[[Page 16037]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Medical Device ISO 13485:2003 
Voluntary Audit Report Submission Pilot Program.'' This guidance 
document is intended to provide information on the implementation of 
the Food and Drug Administration Amendments Act of 2007 (FDAAA), which 
amends the Federal Food, Drug, and Cosmetic Act (the FD&C 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. The Pilot 
Program will be effective June 5, 2012.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Medical Device ISO 13485:2003 Voluntary Audit 
Report Submission Pilot Program'' to the Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002 or 
Office of Communication, Outreach and Development (HFM-40), 1401 
Rockville Pike, suite 200N, Rockville, MD 20852. 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 electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. 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, Rm. 5400, Silver Spring, MD 20993-0002, 
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.

I. Background

    This guidance document is intended to provide information on the 
implementation of section 228 of FDAAA (Pub. L. 110-85), which amends 
section 704(g)(7) of the FD&C Act (21 U.S.C. 374(g)(7)). Under this 
guidance document, a device manufacturer whose establishment has been 
audited under one of the regulatory systems implemented by the Global 
Harmonization Task Force (GHTF) founding members \1\ using 
International Organization for Standardization (ISO) 13485:2003 
``Medical devices--Quality management systems--Requirements for 
regulatory purposes'' and ISO 13485:2003 Technical Corrigendum 1:2009 
``Medical devices--Quality management systems--Requirements for 
regulatory purposes,'' (ISO 13485:2003) or a national adoption of this 
standard, e.g., EUROPEAN STANDARD EN ISO 13485 July 2003 + AC August 
2009, ``Medical devices--Quality management systems--Requirements for 
regulatory purposes'' (ISO 13485:2003 + Cor 1:2009) (EN ISO 13485:2003/
AC:2009), National Standard of Canada CAN/CSA-ISO 13485:03 (ISO 
13485:2003) ``Medical devices -- Quality management systems--
Requirements for regulatory purposes'' (Reaffirmed 2008) (CAN/CAS ISO 
13485 13485:2003)), may voluntarily submit the resulting audit report 
to FDA. If, based on that report, FDA determines that 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,\2\ 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 voluntarily submitted ISO 13485:2003 ``Medical devices--Quality 
management systems--Requirements for regulatory purposes'' and ISO 
13485:2003 Technical Corrigendum 1:2009 ``Medical devices--Quality 
management systems--Requirements for regulatory purposes,'' (ISO 
13485:2003) audit report provides FDA a degree of assurance of 
compliance with basic and fundamental quality management system 
requirements for medical devices.
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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 Ministry 
of Health, Labour and Welfare System for Medical Devices and In-
Vitro Diagnostics.
    \2\ See February 2, 2011, Compliance Program (CP) 7382.845 
Inspection of Medical Device Manufacturers Part V http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072753.htm.
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    The medical device ISO 13485:2003 Voluntary Audit Report Submission 
Pilot Program outlined in the guidance is another way in which FDA may 
leverage audits performed by other GHTF regulators and their accredited 
third parties in order to assist FDA in setting risk-based inspectional 
priorities.
    The draft guidance document entitled, ``Medical Device ISO 
13485:2003 Voluntary Audit Report Submission Program'' was published 
for comment in the Federal Register of May 20, 2010 (75 FR 28257). 
Comments on the collection information were due July 19, 2010, and 
comments on the draft guidance document were due by August 18, 2010.
    FDA received comments and suggestions to pilot this program for a 
period of time; an evaluation will follow to allow both FDA and 
industry to work out potential issues, obstacles, and resource 
allocations. FDA agrees and has decided to pilot this ISO 13485 
Voluntary Audit Report Submission Program for a period of 2 years 
effective June 5, 2012. FDA will then evaluate the program and report 
on the findings and any issues or suggested changes.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on ``Medical Device ISO 13485:2003 Voluntary 
Audit Report Submission Pilot 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 guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov or from the 
CBER Internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive 
``Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot 
Program'' you may either send an email request to dsmica@fda.hhs.gov to

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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 
1746 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The 
collection(s) of information in this guidance was approved under OMB 
control number 0910-0700. This final guidance also refers to currently 
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 are currently 
approved under OMB control number 0910-0073 and the collections of 
information for the Inspection by Accredited Persons Program are 
currently approved under OMB control number 0910-0569.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments 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: March 13, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6503 Filed 3-16-12; 8:45 am]
BILLING CODE 4160-01-P


