510(k)
Medical abbreviation · Medical Research
| Stands for | Premarket notification (FDA section 510(k)) |
|---|---|
| Categories | Medical |
510(k) stands for Premarket notification (FDA section 510(k)), a medical research abbreviation.
FDA clearance pathway for most moderate-risk (class II) medical devices, in which the manufacturer shows the new device is substantially equivalent to a legally marketed predicate device. Clearance is usually faster and requires less clinical data than premarket approval.
Example: The new infusion pump received 510(k) clearance citing an earlier model as its predicate.
Usage notes
Named for section 510(k) of the Federal Food, Drug, and Cosmetic Act, added by the Medical Device Amendments of 1976. Devices are "cleared" through 510(k) rather than "approved". Critics argue that chains of predicates can let devices reach the market without adequate testing, and the De Novo pathway serves novel low-to-moderate-risk devices without a predicate.
Related abbreviations
More medical research abbreviations
- AHRQ – Agency for Healthcare Research and Quality
- ARR – Absolute risk reduction
- AUC – Area under the receiver operating characteristic curve
- BTD – Breakthrough therapy designation
- CBER – Center for Biologics Evaluation and Research
- CDER – Center for Drug Evaluation and Research
- CEA – Cost-effectiveness analysis
- CI – Confidence interval
- CITI – Collaborative Institutional Training Initiative
- COI – Conflict of interest
- CONSORT – Consolidated Standards of Reporting Trials
- CPG – Clinical practice guideline
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This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.