Medical DevicesLast reviewed April 2026

Class III Medical Device(Class III)

Highest-risk medical devices requiring Premarket Approval (PMA) based on clinical evidence of safety and effectiveness.

Usage Examples

The Class III implantable cardioverter-defibrillator required a PMA supported by a 600-patient pivotal trial.
A PMA supplement was filed for the design change to the Class III device.

What is Class III?

Class III devices support or sustain human life, are of substantial importance in preventing impairment of human health, or present potential unreasonable risk of illness or injury. They require Premarket Approval (PMA) — the most rigorous FDA device pathway — based on valid scientific evidence including typically well-controlled clinical trials.

About 10% of FDA-regulated devices are Class III. Examples include heart valves, implantable defibrillators, breast implants, and certain diagnostic devices for serious conditions. PMA review takes 180 FDA days plus sponsor clock time for Additional Information responses; actual elapsed time is typically 1-3 years. Advisory Committee review is common for novel Class III devices. Approved PMAs have ongoing postmarket obligations including annual reports, PMA supplements for changes, 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, FDCA SECTION 513.

FDA CDRHEMAHealth Canada

When This Matters

The Class III implantable cardioverter-defibrillator required a PMA supported by a 600-patient pivotal trial.
A PMA supplement was filed for the design change to the Class III device.

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 515FDCA SECTION 513

Frequently Asked Questions

No. Class III devices require PMA. The only exception is pre-amendments Class III devices that FDA has not yet called for PMA — these can be 510(k)-cleared based on substantial equivalence to a pre-amendments predicate, but FDA is working to transition all these to Class II or require PMA.

FDA statutory review is 180 days. With advisory committee, Additional Information responses, and amendments, actual elapsed time typically runs 1-3 years for a new PMA. Modular PMAs can enable review of CMC content earlier to compress the overall timeline.

No. De Novo is for novel low-to-moderate risk devices. Genuinely Class III devices (supporting life, substantial importance in preventing impairment) require PMA. If risk analysis shows the device is actually Class II, De Novo becomes available.