Guideline

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Annual Reports for Approved Premarket Approval Applications (PMA)
Internet:	http://www.fda.gov/cdrh/ode/guidance/1585.pdf
Origin/Publisher:	FDA
Content:	This guidance describes information required by 21 CFR 814.84 (b) and the recommendations for the level of detail you should provide in your annual report.
Status:	Draft
Document Type:	Draft