FDA Approval
Also known as: PMA, Premarket Approval, NDA
The FDA's authorization for a medical device or drug to be marketed in the US, granted through the PMA or NDA pathway after demonstration of safety and efficacy.
Full Definition
PMA (Premarket Approval) is required for Class III devices that cannot demonstrate substantial equivalence to a predicate. It requires clinical data demonstrating safety and efficacy and is significantly more expensive and time-consuming than 510(k) clearance — typically $1M–$10M+ and 1–3 years. NDA (New Drug Application) is the equivalent pathway for drugs. De Novo classification provides a pathway for novel devices with no predicate that don't require PMA.
Example
An implantable cardiac device requires PMA because it is a Class III device with no eligible predicate. The company conducts a 500-patient randomized controlled trial over 3 years before submitting to FDA.