Direct comparison
FDA Clearance vs. Approval Explained
FDA clearance (510(k)) and approval (PMA, or NDA/BLA for drugs) rest on different review standards under different laws. What separates them, in plain terms.
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How do 510(k) Clearance, PMA Approval, De Novo Classification compare side by side?
The table below compares 510(k) Clearance, PMA Approval, De Novo Classification across 7 procurement-relevant dimensions, from outcome term fda uses through can the outcome later serve as a predicate for others?.
Side-by-side comparison
| Dimension | 510(k) Clearance | PMA Approval | De Novo Classification |
|---|---|---|---|
| Outcome term FDA uses | Device is "cleared" | Device is "approved" | Request is "granted" — not a clearance or an approval |
| Product types it applies to | Medical devices only | Medical devices only (drugs/biologics use NDA/BLA approval instead — see FAQ) | Medical devices only |
| Legal basis (FD&C Act) | Section 510(k) | Section 515 | Section 513(f)(2) |
| Review standard | Substantial equivalence to a legally marketed predicate device | Independent demonstration of the device's own safety and effectiveness — no predicate involved | No predicate exists, but device risk is low-to-moderate; FDA creates a new classification rather than comparing to a predicate |
| Typical device risk class | Class I or Class II | Class III (life-supporting, life-sustaining, or otherwise highest-risk) | Results in a new Class I or Class II designation |
| Clinical data usually required? | Not usually — FDA can still request it if the predicate comparison leaves a safety question open | Generally yes — the review standard itself is independent safety-and-effectiveness evidence | Sometimes, depending on the device's risk profile |
| Can the outcome later serve as a predicate for others? | Yes — a cleared device can be cited as a predicate in a future 510(k) | No — PMA-approved devices generally aren't used as 510(k) predicates | Yes — once granted, a De Novo device can serve as a predicate for future 510(k) submissions |
Common questions
Common questions about 510(k) Clearance vs PMA Approval vs De Novo Classification
Is "FDA cleared" the same as "FDA approved"?
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No. "Cleared" specifically means a device went through 510(k) premarket notification and FDA found it substantially equivalent to a predicate device already on the market. "Approved" means FDA independently reviewed evidence of the product's own safety and effectiveness with no predicate involved — the outcome for PMA-reviewed devices and for all new drugs and biologics. The two words describe different review standards, not different degrees of the same thing, and using them interchangeably is a factual error in research, regulatory, or grant documentation.
Do drugs and biologics ever get "FDA clearance"?
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No. Clearance is 510(k) terminology and applies only to medical devices. New drugs are reviewed and approved under a New Drug Application (NDA); biologics are reviewed and approved (technically "licensed") under a Biologics License Application (BLA). A drug or biologic is described as FDA-approved, never FDA-cleared.
What is FDA De Novo classification, and is it a clearance or an approval?
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Neither. De Novo is a pathway for a novel, low-to-moderate-risk device that has no legally marketed predicate to compare against, which rules out 510(k), but that doesn't warrant the full evidentiary burden of PMA given its risk level. FDA grants the De Novo request and creates a new device classification; that outcome is described as "granted," not as cleared or approved. A granted De Novo device can then itself become a predicate for future 510(k) submissions.
Which pathway applies to laboratory and diagnostic equipment used in a research setting?
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It depends on the specific device's risk classification, exactly as for any other medical device. Many lab-based in vitro diagnostic (IVD) instruments and test systems go through 510(k) clearance; higher-risk IVDs and novel diagnostic technologies may require PMA approval or De Novo classification instead. The classification determines the pathway, not the setting the device is used in.
Who in a research organization actually needs to know this distinction?
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Regulatory affairs and compliance staff drafting or reviewing submissions and consent language; IRB coordinators evaluating whether a study device's marketing status affects risk classification or informed-consent disclosures; procurement and lab-equipment managers confirming a purchased instrument's actual FDA status before it's used in a study; and grant/proposal writers who need to describe a device's regulatory status accurately rather than using "approved" as a generic stand-in for any FDA marketing authorization.
Going deeper
