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Download Pre-PMA FDA Inspection

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With the trials IMARC has monitored, our experience has been that the FDA has begun inspecting clinical sites after the Sponsor submits their Premarket Approval Application (PMA), the application submitted to the FDA for approval of a Class III device. In this case, however, the FDA contacted one of the sites for a routine inspection months before the PMA was to be submitted. The site inspected was among the top enrollers in this particular study, and was an academic medical center. Some of the challenges presented at this particular site are included in this download.

Preparing for an FDA Audit

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