Refuse to Accept Policy for 510(k)s

On 21 April 2022 the FDA published the final guidance for industry and FDA staff.

The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review. Focusing FDA’s review resources on complete submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible.

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