De Novo vs 510(k) vs PMA

Choosing the correct premarket pathway is one of the most important early decisions in US regulatory strategy.

Comparison table

Feature	510(k)	De Novo	PMA
Device class	I or II	I or II (new type)	III
Predicate required	Yes	No	No
Standard	Substantial equivalence	Reasonable assurance of S&E via general + special controls	Valid scientific evidence of S&E
Clinical data	Not always required	May be required	Usually required (IDE study)
Review time (goal)	90 days	150 days	180 days (standard PMA)
FDA decision term	Clearance	De Novo order (authorisation)	Approval
Creates new device type?	No	Yes	No
Can serve as predicate?	Yes	Yes	No
Changes pathway	New 510(k) or Special 510(k)	New 510(k) using De Novo as predicate	PMA supplement
Fees (approx. FY2026)	~$23K	~$23K	~$430K

Decision guide

Does a valid predicate exist?
  │
  ├── Yes → Is device Class II or exempt Class I?
  │           ├── Yes → 510(k)
  │           └── No (Class III) → PMA
  │
  └── No → Is device low-to-moderate risk?
              ├── Yes → De Novo
              └── No (high risk / Class III) → PMA

Official resources

• FDA — Premarket Submissions: Selecting the Correct Submission