The U.S. Food and Drug Administration (FDA) has issued an updated version of its guidance on premarket approval (PMA) application submissions and reviews for medical devices.
Published in late February, the updated version of its guidance “Acceptance and Filing Review for Premarket Approval Applications (PMAs)” is “not significantly different” from the prior version, originally issued in 2003. Instead, the revision separates the criteria for a PMA filing into acceptance criteria and filing criteria, and further clarifies the necessary elements and contents of the completed PMA application. In this way, the Agency hopes that the revised guidance will help applicants more fully address the pre-clinical and clinical issues required in a PMA, thereby minimizing unnecessary delays in the review and approval process.
As always, this and other guidance documents issued by the FDA are only intended to provide regulators and the industry with insight into the Agency’s current thinking on a given topic, and do not constitute regulations or any other legally enforceable responsibilities.