Devices

510(k), PMA Submission Acceptance Procedures

FDA has issued two final guidances explaining the procedures and criteria the agency intends to use in accepting or refusing a 510(k) or PMA submission. The guidances include checklists to identify the necessary elements and contents of a complete application. FDA says the updates in the documents address provisions in the 21^st Century Cures Act.

The first guidance, Refuse to Accept Policy for 510(k)s, explains the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. The agency says it is critical to distinguish between the completeness of a regulatory submission and the quality of the data provided and any studies conducted in support of the submission. The assessment of the completeness of a 510(k) occurs during the acceptance review, the document says, while assessment of the quality of the submitted information occurs during the substantive review.

The second guidance, Acceptance and Filing Reviews for Premarket Approval Applications (PMAs), looks at 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 criteria for PMA filing have been separated into acceptance criteria and filing criteria, the document says. The agency notes that the guidance is not significantly different from the previous PMA filing checklist and guidance document, as the PMA filing criteria defined in the regulation have not changed.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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