FDA Premarket Approval (PMA)
The most rigorous FDA pathway — full safety and effectiveness review for Class III (high-risk or novel) medical devices. PMA is uncommon in routine medical-imaging capital equipment; most diagnostic imaging clears via 510(k). PMA shows up for genuinely new technology categories and a small set of high-risk devices.
How it differs from 510(k)
- Substantial-equivalence does not apply. PMA is a standalone review of safety and effectiveness, with primary data — not a comparison to a predicate.
- Clinical study data required, not optional. Pivotal-trial design, endpoints, and statistical plan are part of the submission.
- Manufacturing inspection required pre-approval.
- Review time is measured in calendar years, not 90 days.
- Approval letter language — "approved", not "cleared".
- Significantly more expensive for the manufacturer; approval volumes per year are an order of magnitude lower than 510(k) volumes.
Examples in imaging
- Digital breast tomosynthesis (DBT) — Hologic Selenia Dimensions 3D tomosynthesis received PMA approval in 2011, establishing the regulatory category. Subsequent DBT systems from other vendors followed.
- Contrast-enhanced mammography (CEM) — vendor-specific PMA approvals.
- Specialty therapeutic devices in radiation oncology.
- Class III AI / SaMD — selected high-risk AI-as-medical-device tools.
PMA supplements
- Panel-track supplement — major change in design or labeling; requires advisory-panel review.
- 180-day supplement — significant change requiring full review without panel.
- Real-time supplement — minor changes reviewed during a meeting.
- Special PMA supplement — limited changes (manufacturing, labeling) that don't affect safety or effectiveness.
Why it matters to buyers
- A PMA-approved device has been through the deepest regulatory scrutiny available. The clinical-evidence base is more robust than for 510(k)-cleared devices.
- PMA number identifies the approved device — used for due diligence and adverse-event correlation.
- PMA supplements are part of the device's regulatory history; major configuration changes may have their own supplement numbers.
- Refurb implications — selling a refurbished PMA-approved device requires the device to remain in its approved configuration; non-approved modifications void the approval status.
What PMA doesn't replace
- Doesn't substitute for state-level state radiation registration.
- Doesn't substitute for ACR accreditation or MQSA (mammography).
- Doesn't cover post-market surveillance — that's MAUDE and FDA recalls.