ISO 13485:2003 Voluntary Audit Report Submission Program

Le Chiffre

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#1
Saw this published today. Does this mean that FDA would respect the findings of an external ISO 13485 audit and not perform their own?
http://edocket.access.gpo.gov/2010/2010-12098.htm said:
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program.'' This draft guidance is intended to provide information on the implementation of a section of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amends a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 This draft guidance is not final nor is it in effect at this time.
Under this draft guidance, device manufacturers whose establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF)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.
 
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Sidney Vianna

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#2
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.
 
D

Dudes

#3
In the draft guidance, they speak mostly from Canadian companies. Would European companies also be concerned by such a scheme?
 
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L

Laura Halper

#4
Just to clarify: The GHTF was established January 1993. The founding members were the European Union, the United States, Canada and Japan. Australia joined in November 1993.
 
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