U.S. FDA Releases Guidances on PMAs, 510(k)s

The U.S. Food and Drug Administration (FDA) has recently released two guidance documents that signal an effort by the agency to provide medical device manufacturers with more timely feedback on premarket approval applications (PMAs) and 510(k) submissions.

Released in late January, the first guidance, “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs),” discusses the FDA’s decision to: 1) separate the criteria for PMA filings into acceptance criteria and filing criteria; 2) conduct an assessment regarding the acceptance criteria promptly upon receipt of an application; and 3) notify the applicant within 15 calendars of receipt of their application whether all application criteria have been met.

The second guidance, “Refuse to Accept Policy for 510(k)s,” adopts a similar approach with regard to medical devices subject to the FDA’s 510(k) submission policy. The guidance stipulates a timely acceptance review of the submission for completeness, and to inform a submitter within 15 calendar days after receipt of their submission whether it is administratively complete. This acceptance assessment reviews only the completeness of the submission and not the quality of data submitted in support of the submission, which takes place during the agency’s more substantive review of the submittal.

As always, guidance documents are solely intended to provide stakeholders with an understanding of the FDA’s current thinking on a given topic, and do not have the force of law and do not bind the agency in any way. Nonetheless, these guidance documents promise increased clarity for medical devices manufacturers seeking authorization to market their products in the U.S.

Read the complete text of the FDA’s guidance on PMAs.

Read the text of the guidance on 510(k)s.

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