Draft Guidance Addresses Company Requests For Rationale Of FDA Decisions

The document offers FDA’s interpretation of the terms “substantive summary” and “significant decisions,” both of which appear in new statutory provisions related to the longstanding process for manufacturers to appeal an agency decision.

A draft guidance published May 17 describes the type of information FDA will provide in the substantive summary it is legally obligated to provide to a device company seeking to know the rationale behind a pre-market review decision.

The document, “Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A,” offers FDA’s interpretation of the...

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