FDA Issues Draft Guidance on Pre-Submission Program to Help Device Makers Gain Early Agency Feedback | GenomeWeb

Originally published July 12.

Expanding on its pre-investigational device exemption, or pre-IDE, program, the US Food and Drug Administration issued draft guidance this week on a new effort called the Pre-Submission Program, through which device manufacturers can seek FDA's input on an investigational device before formally applying for regulatory approval.

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