PMA
Medical abbreviation · Medical Research
| Stands for | Premarket approval |
|---|---|
| Categories | Medical |
PMA stands for Premarket approval, a medical research abbreviation.
FDA's most stringent review pathway for medical devices, required for most high-risk class III devices such as implantable defibrillators, heart valves and some diagnostic tests. Manufacturers must provide valid scientific evidence, usually including clinical trials, that the device is safe and effective.
Example: The transcatheter valve received PMA after its pivotal trial met the primary endpoint.
Usage notes
PMA review includes inspection of manufacturing facilities and often an advisory panel meeting. Changes to an approved device require PMA supplements. Devices approved through PMA have some protection from state product liability claims under the 2008 Supreme Court decision Riegel v. Medtronic.
Related abbreviations
More medical research abbreviations
- OR – Odds ratio
- PBO – Placebo
- PCORI – Patient-Centered Outcomes Research Institute
- PDUFA – Prescription Drug User Fee Act
- PI – Principal investigator
- PICO – Population, Intervention, Comparison, Outcome
- PMID – PubMed identifier
- PP – Per-protocol (analysis)
- PPV – Positive predictive value
- PRISMA – Preferred Reporting Items for Systematic Reviews and Meta-Analyses
- PRO – Patient-reported outcome
- PROM – Patient-reported outcome measure
See all 94 medical research abbreviations →
This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.