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IDE “Clinical Holds” Can Prompt Industry Request For FDA Rationale

A final guidance on so-called 517A requests, in which companies can request a substantive summary of FDA’s rationale for certain decisions, puts an agency halt of a device trial on the list of actions that qualify for such a request. That is a new addition from the 2013 draft version.

An FDA decision to halt an investigational device exemption trial based on patient-safety concerns is grounds for the affected company to receive a detailed rationale for the decision upon request, the agency says in a July 30 guidance document.

The addition of an IDE clinical hold to the list of qualifying “significant decisions” that are subject to a company...

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