FDA plans to allow device manufacturers to submit ISO 13485:2003 audit results to the FDA. The program would allow FDA to evaluate the results, conduct a risk assessment, and remove the manufacturer from FDA’s routine work plan for one year.
The program implements one of the changes of the Food and Drug Administration Amendments Act of 2007, which allows these voluntary submissions. The law allows voluntary audit report submissions, but requires all repots during the preceding two-year period.
The draft guidance document requires submission of the report within 60 days from the last day of the most recent audit. The submission must include all ISO 13485:2003 audit reports issued during the preceding two-year period.
Docket number FDA-2010-D-0226 includes the draft guidance document and additional information published in the Federal Register. You can review and download these documents as well as comments from http://www.regulations.gov/search/Regs/home.html#home
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The comment period on this draft guidance closes on August 18, 2010.