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Industry Says FDA Should Broaden Scope Of Pre-Submission Program

FDA should allow pre-submission meetings to occur earlier in a device’s development cycle than what is stated in the recent draft guidance, industry groups say. The agency should also agree to review prior data as part of these meetings.

FDA should expand the scope of device pre-submission meetings to allow for earlier interactions between the agency and companies, and broaden areas of discussion to include initial clinical data collected by firms, industry groups told FDA in comments on the recent pre-submission program draft guidance.

The draft guidance, released in July, outlines the goals for the agency’s pre-submission device program, dubbed Pre-Sub, and sets a more structured process for pre-submission meetings with industry

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