Premarket approval (PMA) by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices.

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) established the PMA regulatory pathway for new medical devices.¹ 

The 2016, 21st Century Cures Act revised policies and processes related to PMA by expanding the application of the “least burdensome” principles in premarket reviews. In a review using the least burdensome principle, the FDA accepts the minimum amount of information necessary to adequately address a relevant regulatory question or issue (i.e. using less burdensome sources of clinical data, using nonclinical data, etc.).^{1, 2}

Revisions to the PMA process were intended to speed patient access to new medical devices by ensuring the most efficient review while still adhering to the applicable statutory and regulatory standards.

In addition to establishing the PMA regulatory pathway the Medical Device Amendments of 1976 to the FD&C Act established three regulatory classes for medical devices, based on the degree of control necessary to ensure safety and efficacy.¹ The most regulated devices are in Class III, all devices placed into Class III are subject to PMA requirements. The process of submitting a PMA application is informal, with no actual PMA form. The FDA outlines the necessary components for the PMA submission:

• Table of contents and cover letter

• Abstract section 

• Results of laboratory studies on human subjects, both clinical and non-clinical, separated in individual sections 

• Indications for use section

• Device description section

• Section outlining any possible alternative practices or uses for the device

• References for design and manufacturing standards (regulatory and self-imposed)

• Study conclusion & marketing research

• Disclosure of any trade or secretive information/materials used throughout

• Any relevant updates to the device, marketing plan, or production³

The FDA review of an application for PMA should take six months, according to agency statements; however, on average it takes 274 days.³

Only 10% of medical devices are considered Class III and require a PMA application.⁴

As of March 2017, PMA rate was 100 percent. As of November 31, 2020, the FDA approved 31 devices through the PMA process in 2020.⁵

1. A History of Medical Device Regulation and Oversight in the US. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states. Published 2019.

2. U.S. Food and Drug Administration. The Least Burdensome Provisions: Concept And Principles. Silver Spring, MD; 2019.

3. Rish T. Understanding the Premarket Approval (PMA) Process. Greenlight Guru Medical Device Blog. 2021. https://www.greenlight.guru/blog/premarket-approval-pma. 

4. What’s the Difference Between the FDA Medical Device Classes?. Blog. https://bmpmedical.com/whats-difference-fda-medical-device-classes-2/.

5. Silvestrini E. Premarket Approval (PMA) Process. Drugwatch.com. https://www.drugwatch.com/fda/premarket-approval/#:~:text=The%20FDA%20review%20of%20an,year%2C%20it%20was%20262%20days. Published 2020.