Standards · Standard or regulation
FDA 510(k) / De Novo / PMA
US premarket pathways for medical devices
In plain words
What it covers.
The routes a device takes to reach the US market. Devices are Class I, II or III by risk. A 510(k) shows a new device is substantially equivalent to a legally marketed predicate. De Novo is for new low to moderate risk devices with no predicate. Premarket Approval (PMA) is for Class III devices and needs strong clinical evidence of safety and effectiveness.
Who uses it: Manufacturers and regulatory affairs teams planning a US launch; design teams choosing a pathway early.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Device classification I, II, III
- 510(k) premarket notification
- Substantial equivalence and predicates
- De Novo classification request
- Premarket approval (PMA)
- Investigational device exemption (IDE)
Key points
What engineers need to know.
- Most Class I and some Class II devices are exempt from premarket review.
- A 510(k) needs a predicate device with the same intended use and similar technology.
- De Novo creates a new classification that later devices can use as a predicate.
- PMA is the most demanding route and usually needs clinical trials.
- Clinical studies of significant risk devices need an IDE before they start.
- Changing a cleared device may need a new 510(k).
Medical City
Where you practise it.
- Design Studio regulatory pathways stage (510(k), De Novo, PMA, EU MDR)