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