A 510(k) is a premarket submission made to FDA to demonstrate that a device to be marketed in the U.S. is as safe, effective and substantially equivalent to a pre-existing legally marketed device.
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 and premarket notification (510(k)) regulatory pathway for new medical devices.
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.). The 21st Century Cures Act also streamlined processes for exempting devices from the premarket notification (510(k)) requirement.
Revision to the PMA process and the 510(k) exemption were intended to speed patient access to new medical devices. By improving the processes, the FDA ensures that safe and effective, life-saving devices make it to patients as early as possible.
A crucial distinction between the PMA and 510(k) is whether a device is generic. Generally if you’re developing a medical device that is similar to one already on the market, the 510(k) regulatory pathway is the correct route; however if the device is completely new then PMA is required. A 510(k) should be submitted at least 90 days before the device is marketed. A 510(k) submission should elucidate how the device is different from previously approved devices but maintains the same levels of safety and efficacy, and intended use. The 510(k) submission will need to include laboratory testing results, human data is however, generally, not required. If the 510(k) submission is for a device that has been significantly altered, results from clinical trials may be necessary. If the device is new to the market or classified as a Class III device, meaning the device is high risk for the patient, you’ll be required to apply for PMA. The FDA requires extensive evidence to determine that the device is safe and effective, i.e., laboratory and clinical trial data.
Only 10% of medical devices are considered Class III and require a PMA application.
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.
Standridge L. Premarket Notification 510(k) and Premarket Approval. The Quality & Compliance Hub. 2021. https://www.qualio.com/blog/whats-the-difference-between-premarket-notification-510k-and-premarket-approval-pma.
What’s the Difference Between the FDA Medical Device Classes?. Blog. https://bmpmedical.com/whats-difference-fda-medical-device-classes-2/.