PMA submission software for Class III devices.
The Premarket Approval application is the FDA’s most rigorous device pathway. REGARA keeps its clinical, non-clinical, and manufacturing evidence organized, current, and defensible.
Premarket Approval (PMA) is the FDA process for the highest-risk Class III devices — those that support or sustain life, are implanted, or present a potential unreasonable risk of illness or injury. Unlike a 510(k), a PMA must demonstrate a reasonable assurance of safety and effectiveness on its own evidence, typically including clinical trial data.
PMAs are large, modular, and often reviewed in stages. They combine clinical study reports, non-clinical bench and animal testing, and detailed manufacturing (CMC-style) information, frequently accompanied by an FDA advisory panel review and a facility inspection.
REGARA holds the whole application together — drafting each module against current guidance, tracking amendments, and keeping every claim anchored to the study or standard behind it.
- 01Modular assembly
Build and track PMA modules as they’re drafted and reviewed, with a live picture of what’s complete, pending, or awaiting FDA feedback.
- 02Clinical evidence integration
Link pivotal-study endpoints and statistical results directly to the safety and effectiveness claims they support.
- 03Manufacturing documentation
Organize device description, manufacturing, and quality information to the level of detail a PMA and pre-approval inspection demand.
- 04Amendment tracking
Manage FDA questions and amendments across review cycles without losing the thread — every change versioned and traceable.
Why a PMA demands more.
It stands alone.
No predicate carries the argument. A PMA must prove safety and effectiveness on its own clinical and non-clinical evidence.
Thousands of pages.
PMAs are among the largest submissions in medicine. Coherence and traceability across modules is the difference-maker.
Panels and inspections.
Advisory panels and pre-approval inspections mean the record has to hold up to direct, expert questioning.
- QWhat is a PMA submission?
A Premarket Approval (PMA) is the FDA’s most stringent device marketing application, required for high-risk Class III devices. It must demonstrate reasonable assurance of safety and effectiveness through the applicant’s own clinical and non-clinical evidence rather than comparison to a predicate.
- QHow is a PMA different from a 510(k)?
A 510(k) demonstrates substantial equivalence to an existing predicate device, while a PMA independently proves safety and effectiveness — usually with clinical trial data, an advisory panel review, and a manufacturing inspection. PMAs apply to higher-risk devices and are far more extensive.
- QDoes a PMA require a clinical trial?
Most PMAs require valid scientific evidence that includes clinical data from a well-controlled investigation, often conducted under an Investigational Device Exemption (IDE). The specific evidence depends on the device and its risks.
- QHow does REGARA support a PMA?
REGARA assembles the PMA modularly, links clinical endpoints and non-clinical results to the claims they support, organizes manufacturing information for inspection readiness, and versions every amendment across review cycles — all with source-anchored traceability.
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Bring order to your PMA.
Show us a module. In a 30-minute working session we’ll draft against current guidance and connect evidence to claims.