Premarket Approval
FDA's most stringent device marketing application, required for high-risk Class III devices.
Definition
Premarket Approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. PMA is the most stringent type of device marketing application required by the FDA.What this means in practice
PMA submissions must include valid scientific evidence, typically from adequate and well-controlled clinical investigations, that the device is safe and effective for its intended use. They also undergo a Pre-Approval Inspection (PAI) of the manufacturing facility. Post-approval, PMA devices remain subject to conditions of approval, post-approval studies, and annual reports.Examples
- An implantable cardiac defibrillator approved via original PMA supported by a pivotal randomized trial.
- A new indication for an existing PMA device pursued through a PMA Supplement rather than a new original PMA.
Use cases
1 scenarioNovel implantable neurostimulator
Clinical & RA teamAn implantable device for treatment-resistant depression has no predicate. The sponsor runs an IDE-authorized pivotal trial, then submits a PMA with full clinical, manufacturing, and biocompatibility data, plus a cybersecurity plan for the patient programmer.
- •Assuming a 510(k) pathway will work for novel high-risk devices. Class III devices default to PMA unless reclassified.
- •Underestimating the manufacturing inspection component (PAI); GMP nonconformities can delay approval regardless of clinical data quality.
- •Building a clinical program without an early FDA Pre-Submission (Q-Sub) meeting to align on endpoints, control, and statistical plan.
- •Confusing PMA approval with 510(k) clearance in labeling and marketing materials.
Frequently asked questions
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
The legal standard a 510(k) device must meet versus a predicate.
FDA's highest-risk device class, generally requiring PMA.
FDA authorization to use an investigational device in a clinical study.
De Novo & Breakthrough Pathways
· From this learning pathPathway to classify novel low- to moderate-risk devices that lack a predicate.
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
Product comprised of two or more regulated components - e.g., drug-device, biologic-device.
Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.
Founder & Investor Primer
· From this learning pathLedger of all securities issued by a company and who owns them.
Short-term debt that converts into equity at a future financing round.
Investigation of a company before an investment, financing, or acquisition.
Valuation ratio applied at exit, e.g., enterprise value to revenue.
Where this term appears across MedTech Terms.
- De Novo & Breakthrough PathwaysLesson 10 of 11
- Founder & Investor PrimerLesson 3 of 16
- 510(k) vs PMAvs 510(k) Premarket Notification
Primary references
3 sources- 1Premarket Approval (PMA)VerifiedFDAfda.gov
- 221 CFR Part 814VerifiedeCFRecfr.gov
- 3PMA Application ContentsUncheckedFDAfda.gov
Inline markers like [1] jump to the matching reference above.