FDA has Published a Guidance for Industry on Acceptance and Filing Review for PMA Applications
Key elements of this Guidance:
– FDA has not changed the requirements, per say. They have split the requirements so there is clarity on what is required for a PMA to be accepted for review.
– The purpose of the Guidance as stated in the Guidance “… is intended to be used by FDA staff and the device industry to help elucidate the broad pre-clinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process.”
-“Focusing the Agency’s review resources on complete applications will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible.”
There is a high degree of value in working closely with FDA from pre-clinical Development through Clinical Development to ensure successful PMA approval in a timely manner. FDA has taken many steps to increase the time to approval of new, innovative devices. Key to timely approval is making sure your firm has fully met FDA’s requirements for the PMA submission.