510(k) — US FDA
Which predicate do I claim, and what evidence proves substantial equivalence?
US FDA premarket approval (PMA)
My device is high risk. What does a PMA actually demand?
- AuthorityUS FDA
- JurisdictionUnited States
- Type Market-access route
- Our scopeCoordinated by Prequel
What this route requires
Premarket approval is the most demanding US device route and applies to most Class III devices — those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.
A PMA requires sufficient valid scientific evidence to establish a reasonable assurance of safety and effectiveness for the device itself. Existing literature and significant human experience with a marketed device may contribute where appropriate, but — unlike a 510(k) — the package cannot rest on equivalence to a predicate, and it normally means generating clinical data.
That makes the study design one of the largest cost decisions in the programme, and it is a decision that has to be made before testing is commissioned rather than after. A study that answers the wrong question is not partially useful; it is a repeat.
Applies to
Most Class III devices, which require an independent demonstration of safety and effectiveness.
Our scope
How Prequel supports it
- Assess PMA feasibility and confirm the route is correct
- Build the safety and effectiveness evidence plan
- Design the clinical strategy against that evidence requirement
- Coordinate assembly of the technical dossier
- Run the submission with a US regulatory specialist and manage FDA questions
Coordinated by Prequel. Evidence planning and clinical strategy are our own work. The FDA filing is run with a US regulatory specialist under our scope and review.
Other routes
Many programmes target more than one market. Evidence generated for one route can often support another, which is worth planning before testing starts rather than after.
De Novo — US FDA
There is no predicate for my device. What route is left?
CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
Not sure PMA — US FDA is your route?
That is what the Readiness Assessment settles. Tell us the product, its intended use and your target market, and we will confirm the pathway before you commit to evidence.