PMA (Premarket Approval)
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Premarket Approval is FDA’s most stringent device review pathway, required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of health, or present a potentially unreasonable risk of illness or injury. Unlike a 510(k), a PMA requires independent evidence of safety and effectiveness, typically including clinical investigation data, rather than comparison to a predicate.
A PMA application must include full reports of all clinical and nonclinical studies, a complete device description and manufacturing information, and proposed labeling, and FDA’s statutory review clock is 180 days — routinely extended in practice by requests for additional information and, for many PMAs, a request for an FDA advisory committee review.
PMA approval is device-specific, not manufacturer-specific: a significant design, manufacturing process, or labeling change to an approved PMA device generally requires a PMA supplement before it can be implemented, and FDA conducts periodic reporting and, where warranted, postapproval study requirements to continue monitoring the device’s real-world risk-benefit profile.
- —Required for Class III devices; the most demanding FDA device pathway
- —Requires independent safety/effectiveness evidence, typically including clinical data — not predicate comparison
- —Statutory review goal is 180 days, often extended for additional information
- —Post-approval changes generally require a PMA supplement before implementation
- —May carry FDA-imposed postapproval study requirements
FD&C Act §515; 21 CFR Part 814
Frequently asked questions
What is PMA (Premarket Approval)?
Premarket Approval is FDA’s most stringent device review pathway, required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of health, or present a potentially unreasonable risk of illness or injury. Unlike a 510(k), a PMA requires independent evidence of safety and effectiveness, typically including clinical investigation data, rather than comparison to a predicate.
Which regulations cover PMA (Premarket Approval)?
FD&C Act §515; 21 CFR Part 814