Direct comparison
510(k) vs De Novo: FDA Device Pathways
Compare FDA 510(k) and De Novo pathways: predicate requirements, review clocks, MDUFA fees, and classification outcomes for medical device development.
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How do 510(k) Premarket Notification, De Novo Classification compare side by side?
The table below compares 510(k) Premarket Notification, De Novo Classification across 10 procurement-relevant dimensions, from statutory authority through when to choose this pathway.
Side-by-side comparison
| Dimension | 510(k) Premarket Notification | De Novo Classification |
|---|---|---|
| Statutory authority | Section 510(k) of the FD&C Act (21 U.S.C. § 360(k)); 21 CFR Part 807 Subpart E | Section 513(f)(2) of the FD&C Act (21 U.S.C. § 360c(f)(2)); 21 CFR Part 860 Subpart D |
| Primary objective | Demonstrate substantial equivalence (SE) to a legally marketed predicate device | Establish risk-based classification into Class I or Class II for a novel device lacking a predicate |
| Predicate requirement | Mandatory; requires an existing legally marketed device with compatible intended use and tech | None allowed; strictly designed for novel device types where no legally marketed predicate exists |
| Device risk tier | Class II (standard) and select non-exempt Class I or preamendment Class III devices | Low-to-moderate risk devices that would otherwise default to Class III under Section 513(f)(1) |
| FDA review timeline goal | 90 FDA calendar days (30 days for Special 510(k); 180-day applicant deficiency hold) | 150 FDA calendar days (15-day technical screening; 180-day applicant deficiency hold) |
| Standard MDUFA fee (FY 2027) | $28,653 standard application fee ($7,163 for CDRH-qualified small businesses) | $191,020 standard application fee ($47,755 for CDRH-qualified small businesses) |
| Electronic submission mandate | Mandatory eSTAR electronic submission format effective October 1, 2023 | Mandatory eSTAR electronic submission format effective October 1, 2025 |
| Authorization outcome | 510(k) Clearance Order under an existing regulation and product code | De Novo Granting Order creating a new 21 CFR regulation, product code, and special controls |
| Subsequent market impact | Clears device for sale; cannot create a new classification code or new special controls | Device immediately becomes a legally marketed predicate for competitor 510(k) filings |
| When to choose this pathway | Choose when a viable predicate device exists in FDA databases with identical intended use | Choose when developing novel low/moderate-risk device with no predicate, avoiding full PMA |
Common questions
Common questions about 510(k) Premarket Notification vs De Novo Classification
What is the difference between 510(k) and De Novo?
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The fundamental difference is predicate availability: a 510(k) requires demonstrating substantial equivalence to an existing legally marketed device, whereas De Novo classifies novel low-to-moderate-risk devices that have no predicate.
How does PMA compare to De Novo and 510(k)?
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Premarket Approval (PMA) is for high-risk (Class III) devices requiring full clinical trials ($636,732 standard fee). De Novo classifies novel low-to-moderate-risk devices into Class I or II ($191,020 fee), while 510(k) clears predicate-matched devices ($28,653 fee).
Can a device cleared through De Novo be used as a predicate?
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Yes. When FDA grants a De Novo request, it creates a new 21 CFR regulation and product code. The authorized device immediately becomes a legally marketed predicate for subsequent competitor 510(k) submissions.
Can you file a Direct De Novo without submitting a 510(k) first?
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Yes. Under Section 513(f)(2) of the FD&C Act, sponsors can submit a Direct De Novo (Option 2) if they determine that no predicate device exists, without first undergoing a 510(k) Not Substantially Equivalent (NSE) determination.
