Devices

PMA Acceptance, Review Guidance

FDA has issued a guidance, Acceptance and Filing Review for Premarket Approval Applications (PMAs), to help describe the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process. The document says that focusing the agency’s review resources on complete applications “will provide a more efficient approach in ensuring that safe and effective medical devices reach patients as quickly as possible.”

Acceptance review is also important because of the performance goals agreed to in all the iterations of the MDUFA program, FDA says.

Criteria for PMA filing have been separated into acceptance criteria and filing criteria. The guidance says acceptance review involves assessment of an application’s completeness, and informing the applicant in a written response within the first 15 calendar days of receipt whether any elements are missing and what they are.

“To enhance the consistency of our acceptance and filing decisions and to help applicants better understand the types of information FDA needs to conduct a substantive review of a PMA,” the document says, “this guidance and associated checklist clarify the necessary elements and contents of a complete PMA application. The process we outline is applicable to all devices reviewed in a PMA application and has been compiled into a checklist for use by FDA review staff.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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