Medical Devices

Premarket Approval(PMA)

The FDA process for approving Class III high-risk medical devices based on clinical evidence of safety and effectiveness.

Usage Examples

The PMA included data from a 500-patient pivotal trial.
FDA convened an advisory panel to review the PMA.
A PMA supplement was required for the design change.

What is PMA?

Premarket Approval (PMA) is the most rigorous FDA regulatory pathway for medical devices, required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment, or present potential unreasonable risk.

PMA applications must contain valid scientific evidence demonstrating reasonable assurance of safety and effectiveness, typically including well-controlled clinical trials. The review process includes administrative review, scientific review, advisory panel review (often), and FDA decision.

PMA review typically takes 180 FDA days (1-3 years actual time). Approved PMAs are subject to postmarket requirements including annual reports and mandatory adverse event reporting.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 814, FDCA SECTION 515.

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When This Matters

The PMA included data from a 500-patient pivotal trial.
FDA convened an advisory panel to review the PMA.
A PMA supplement was required for the design change.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 814FDCA SECTION 515

Frequently Asked Questions

PMA is required for Class III high-risk devices with no predicate or where 510(k) is insufficient. 510(k) is for Class II (and some Class I/III) devices with a substantially equivalent predicate.

PMA typically requires well-controlled clinical trials demonstrating safety and effectiveness. The specific requirements depend on the device type, risk, and intended use.

Changes to an approved PMA (design, labeling, manufacturing) may require PMA supplements. Types include 180-day supplements, Real-Time supplements, 30-day notices, and annual reports depending on the change.