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Acceptance and Filing Reviews for Premarket Approval Applications

Acceptance and Filing Reviews for Premarket Approval Applications 2025

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The document provides guidance from the FDA regarding the acceptance and filing reviews for Premarket Approval Applications (PMAs) for medical devices. It outlines the criteria and processes that FDA staff and industry should follow to ensure that PMAs are complete and meet regulatory requirements. The guidance emphasizes the importance of focusing on complete applications to expedite the review process, thereby facilitating timely access to safe and effective medical devices. It includes checklists for both acceptance and filing reviews, clarifying necessary elements for a successful PMA submission.

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What is the difference between 510K and premarket approval?

Whats the difference between a 510K vs PMA? 510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.

What is a premarket review?

Overview. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

How long does it take for PMA to be reviewed?

Within 180 days of the date of filing of the PMA (814.40), FDA will complete its review of the PMA and of the advisory committee`s report and recommendation and issue one of the following: an approval order under 814.44(d), an approvable letter under 814.44(e), a not approvable letter under 814.44(f), or.

What is the most stringent requirements of premarket approval?

PMA is the most stringent type of device marketing application that FDA requires. To market a Class III device, the premarket approval application (PMA) must establish a reasonable assurance of safety and effectiveness, as demonstrated by valid scientific evidence.

How long does premarket approval take?

The PMA process can take between 9 and 36 months before approval is granted, and with the addition of required clinical studies, it may take several years before a product is approved.

What is the FDA guidance on pre-approval promotion?

Generally the FDA does not allow pre-clearance/approval promotion, but it does tolerate a fair amount of communication about a product pre-clearance/approval. The following are a list of activities with a brief synopsis of what generally can and cannot be done by a medical device company prior to clearance/approval.

Acceptance and Filing Reviews for Premarket Approval Applications 2025

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