FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
US FDA premarket approval (PMA)
My device is high risk. What does a PMA actually demand?
What this route requires
Premarket approval is the most demanding US device route and applies to Class III devices — those supporting or sustaining life, of substantial importance in preventing impairment, or presenting an unreasonable risk of illness or injury.
Unlike a 510(k), a PMA cannot lean on anything already on the market. It has to establish safety and effectiveness on its own evidence, which normally means clinical data.
That makes the study design the single largest cost decision 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
Class III devices requiring 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 — it is the same discipline as the trials we run in India. 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.
AYUSH — ASU products
What licence does an Ayurvedic or herbal product need, and who issues it?
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.