USFDA Medical Device Premarket Approval Overview

The USFDA Premarket Approval (PMA) process is one of the device registration pathways provided by the US FDA, primarily designed for FDA Class III medical devices. The FDA PMA approval process for Class III devices entails meticulous scientific and regulatory evaluations to assess the medical device's safety and efficacy, ensuring the highest standards are met prior to the market authorization.

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Who Should Submit a USFDA Medical Device Premarket Approval (PMA) Application?

Device manufacturers must submit a PMA application if the device:

• Is novel.
• Belongs to a high-risk class.
• Cannot be found in the Product Classification Database.
• Is not substantially equivalent (NSE) to Class I, II, or III devices.

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What is the Difference Between 510(k), PMA, and De-Novo Applications?

What are the Different FDA Premarket Approval Application Methods?

Manufacturers can opt for any of the following four (04) PMA application methods that would be best suited for their device: 

• Traditional PMA
• Modular PMA
• Product Development Protocol
• Humanitarian Device Exemption

What are the Data Requirements for Medical Device Premarket Approval?

According to 21 CFR part 814, applicants must submit a duly filled CDRH application form, required undertakings, and a well-drafted PMA technical file to the US FDA. The technical file shall include the non-clinical and clinical data.

Non-clinical Data – It consists of data on microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests.

Clinical Data – It consists of data on study protocols, safety and effectiveness data, adverse reactions and complications, device failures, and replacements, patient information, patient complaints, tabulations of data from all individual subjects, results of statistical analyses, and any other information from the clinical investigations.

What is the PMA Application Process?

What are the Post Approval Compliance Requirements for PMA?

The devices approved under the PMA pathway shall comply with the post-marketing requirements set forth by the USFDA. The device must comply with the following:

• Post-approval requirements imposed in the FDA PMA approval order.
• Post-approval changemanagement through timely submission of relevant PMA supplements
• Submission for post-approval (annual) reports
• 21 CFR 803 regulations for Medical Device Reporting (MDR)
• Post-market Surveillance Studiesas required by the USFDA in the PMA approval orders.

What is the USFDA fees for reviewing the PMA application?

The MDUFA user fees for original PMA and supplements is as below-

With expertise in handling PMA submissions, Freyr can assist in identifying and compiling the information and assist in the preparation and review of the application.