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Premarket Approval Application (PMA)
Practical Law Glossary Item w-003-1237 (Approx. 3 pages)
Glossary
Premarket Approval Application (PMA)
A federal application to sell or market most Class III medical devices in the US under Section 515 of the Food, Drug, and Cosmetic Act (21 U.S.C. § 360e). Class III medical devices are those that cannot be classified Class I or Class II because safety and effectiveness cannot be assured through requisite controls and either:
- Are purported or represented to:
- support or sustain human life; or
- be substantially important in preventing impairment of human health.
- Present a potential, unreasonable risk of illness or injury.
Some Class III device types marketed before 1976 do not require a PMA. Manufacturers of those devices can instead submit a premarket notification to the Food and Drug Administration (FDA). The FDA's website provides a useful discussion of when a PMA is required.
The PMA must include, among other things:
- A full description of the device, its indications for use, and any marketing history.
- Summaries and results of non-clinical and laboratory testing and human clinical studies conducted (including whether the study was conducted under an investigational device exemption).
- A full description of the facilities, methods, and controls used to manufacture and package the device.
This information allows the FDA to determine whether the device is safe and effective in all its proposed uses, and whether the device's benefits outweigh the risks.
For more information, see Practice Note, FDA Medical Devices Regulations: Premarket Approval Application.