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Medical Devices

PMA(Premarket Approval)

PMA is the FDA's most stringent device marketing application, the pathway by which a Class III device wins approval on its own clinical and nonclinical evidence rather than by demonstrating equivalence to a marketed predicate.

Usage Examples

  • We have no predicate, so the pathway is a PMA, not a 510(k).
  • That design change touches the sterilization cycle, so it needs a PMA supplement before we ship.
  • The periodic report on the approved PMA is due next month.

What is PMA (Premarket Approval)?

PMA is the FDA's most stringent device marketing application, the pathway by which a Class III device wins approval on its own clinical and nonclinical evidence rather than by demonstrating equivalence to a marketed predicate.

PMA exists because a Class III device carries risk that general and special controls cannot contain, and no marketed predicate exists whose safety record can stand in for its own. FDA therefore refuses to infer that the device works. The sponsor must prove it directly, with evidence generated on the device itself, before any unit is sold.

PMA applies to any Class III medical device unless it is exempt under section 520(g) of the act, and covers the full evidence package: nonclinical testing, manufacturing, labeling, and clinical results. PMA does not cover Class I or Class II devices, novel low-to-moderate-risk devices routed through De Novo, or investigational use, which runs under an IDE instead.

PMA is applied as a lifecycle obligation, not a one-time filing. After approval, the holder carries postapproval requirements imposed in the approval order, files periodic reports, and must clear a PMA supplement before any change affecting safety or effectiveness reaches the market. The recurring work inside a device company is supplement traffic, not the original submission.

Not to be confused with

510(k)
a 510(k) clears a device by demonstrating substantial equivalence to a legally marketed predicate. A PMA approves a device on evidence generated on that device. Clearance is not approval, and the two words are not interchangeable in labeling.
De Novo
De Novo classifies a novel device with no predicate down into Class I or Class II based on risk. A PMA reclassifies nothing; it approves a device that stays in Class III.
IDE
an IDE authorizes the clinical study that generates the data. The PMA is the marketing application that later submits that data for approval. One permits research, the other permits sale.
PMA supplement
a supplement modifies an already-approved PMA for one specific change. It is not a new application and does not reopen the original approval, so routing a change to the wrong vehicle breaks change control.

The obligations attach first to the device, then to the approved application for as long as it stays on the market.

What you must do

  1. 1Submit a PMA for any Class III medical device before marketing it, unless the device is exempt under section 520(g) of the act21 CFR 814.1
  2. 2Include a section reporting the results of the clinical investigations involving human subjects with the device21 CFR 814.20(b)(6)(ii)
  3. 3Obtain FDA review and approval of a PMA supplement before making any change affecting the safety or effectiveness of the approved device21 CFR 814.39(a)
  4. 4Meet the postapproval requirements FDA imposes in the approval order or by regulation at the time of approval21 CFR 814.82(a)
  5. 5Comply with Part 803 adverse event reporting and the other reporting duties placed on the holder of an approved PMA21 CFR 814.84(a)

Common mistakes

  • Calling a PMA device "FDA cleared"

    clearance belongs to the 510(k) pathway; a PMA device is approved. The error shows up in labeling, websites, and investor decks, creates avoidable promotional-claim exposure, and tells reviewers and partners that the team does not know its own pathway.

  • Treating approval as the finish line

    approval starts the postapproval phase. Postapproval requirements written into the approval order, Part 803 reporting, and periodic reports run for the life of the device. Teams that staff down after approval discover the gap during inspection, when the approval itself is what is at stake.

  • Assessing a change after it has shipped

    the supplement must be approved before the changed device is marketed. Deciding retrospectively whether a change was significant means product left the building against an unapproved configuration, and the remedy is a field action and recall exposure, not a documentation cleanup.

When This Matters

  • We have no predicate, so the pathway is a PMA, not a 510(k).
  • That design change touches the sterilization cycle, so it needs a PMA supplement before we ship.
  • The periodic report on the approved PMA is due next month.

Frequently Asked Questions

A PMA is required when the device is Class III and cannot be cleared by demonstrating substantial equivalence to a legally marketed predicate. The 510(k) route borrows the safety and effectiveness record of an existing device; a PMA forces the sponsor to establish safety and effectiveness on the device's own nonclinical and clinical evidence.

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