FDA offering new guidance to medical device makers

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Medical-device manufacturers seeking FDA approval to market new products will need to pay a user fee unless the device is intended solely for pediatric use or is being made by a state or federal entity and will not be commercially distributed.

That’s among the pointers in a batch of guidance documents the agency is releasing this week. The documents cover user fees, product pre-submissions and the ways in which on-the-ground actions affect performance goals laid out in the fourth iteration of FDA’s Medical Device User Fee Amendments (MDUFA IV)

RAPS, the Regulatory Affairs Professional Society, summarizes the release in an Oct. 3 post.

“FDA has also updated another guidance on its pre-submission program for medical devices to reflect changes to the scheduling of pre-submission meetings and how quickly FDA is expected to provide feedback to device makers following a pre-submission meeting,” writes RAPS news editor Michael Mezher.

To read the full post, which includes links to the relevant FDA documents, click the headline below.