FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
US FDA 510(k) premarket notification
Which predicate do I claim, and what evidence proves substantial equivalence?
What this route requires
A 510(k) is a premarket notification demonstrating that a device is substantially equivalent to a legally marketed predicate. It is the route for most moderate-risk devices where a suitable predicate exists.
Everything turns on the predicate. It fixes the comparison for intended use and technological characteristics, and therefore determines which performance testing you have to produce. Choosing a predicate because it is convenient rather than because it is defensible is the most common reason a submission stalls.
Since 1 October 2023 all 510(k) submissions, unless specifically exempted, must be made electronically using eSTAR — an interactive template that enforces a fixed structure. It reduces administrative rejections, but it also means gaps in the evidence are visible immediately rather than at review.
A foreign manufacturer may hold the 510(k) directly. Separately, any foreign establishment whose devices are imported into the US must identify a US Agent — a requirement that is often confused with the submission itself. The US Agent has no responsibility for the 510(k); the two are different obligations with different consequences.
Applies to
Moderate-risk devices entering the US market where a suitable predicate exists.
Our scope
How Prequel supports it
- Identify and evaluate candidate predicate devices, and document why the chosen one holds
- Build the substantial equivalence comparison for intended use and technological characteristics
- Map the performance testing that comparison requires
- Assemble the evidence into the eSTAR structure
- Run the submission with a US regulatory specialist and manage FDA questions
Coordinated by Prequel. We build the predicate strategy, the equivalence argument and the submission package. The filing itself is run with a US regulatory specialist under our scope and review — we do not hold FDA submission experience in house, and we would rather tell you that now than after you have signed.
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 510(k) — 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.