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FDA Addresses Pre-Submission Meetings In Draft Guidance

With the draft guidelines, FDA takes a step toward fulfilling one of its commitments under the reauthorized device user fee program to establish a more structured process for pre-submission meetings with industry.

FDA released a draft guidance July 12 on its evolving program for providing feedback to device sponsors prior to a company making a pre-market submission.

The draft guidelines, focusing on the agency’s pre-submission device program, dubbed Pre-Sub, are a step by FDA toward fulfilling one of its commitments under the reauthorized device user fee program, enacted last week

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