FDA 510(k) Glossary · regulatory

FDA Review Panel

An FDA review panel is one of 20 medical specialty groups within the Center for Devices and Radiological Health (CDRH) that evaluates 510(k) submissions. The panel assigned to a submission is determined by the device's product code and significantly affects average review timelines, NSE rates, and required technical expertise.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
20 FDA review panels in the dataset. Obstetrics/Gynecology is the slowest at 160 days avg; Chemistry and Toxicology the fastest at ~86-88 days.

Definition

The FDA's Center for Devices and Radiological Health (CDRH) organizes its 510(k) review function into 20 specialty panels, each corresponding to a clinical discipline. The panel assigned to a submission is determined by the device's product code and governs which reviewers evaluate the submission, what precedents apply, and how substantial equivalence arguments are assessed.

All 20 FDA Review Panels

PanelSubmissionsAvg DaysNSE
Anesthesiology8,948139Low
Cardiovascular18,004124Low
Chemistry13,22188Low
Dental12,535127Lowest (9)
ENT3,79188Low
Gastroenterology/Urology9,82412947
General & Plastic Surgery18,146114Low
General Hospital17,734128Low
Hematology3,291112Low
Immunology3,781104Low
Medical Genetics1939942%
Microbiology7,03810062
Neurology6,21414654
Obstetrics/Gynecology4,469160Low
Ophthalmic5,094108Low
Orthopedic17,766122Low
Pathology1,099742.1%
Physical Medicine5,431115Low
Radiology15,452106Low
Toxicology3,02686Low

FDA References

Related Terms

Product Code - Not Substantially Equivalent - 510(k) Premarket Notification - Substantial Equivalence

Frequently Asked Questions

An FDA review panel is one of 20 medical specialty groups within CDRH that evaluates 510(k) submissions. Each panel corresponds to a clinical specialty - such as Cardiovascular, Orthopedic, or Radiology - and employs reviewers with relevant expertise. The panel is determined by the device's product code and affects both the review timeline and the depth of scrutiny applied.

Based on 510k Database records, the Chemistry and Toxicology panels have the fastest average review times at approximately 86-88 days. The Obstetrics and Gynecology panel is the slowest at an average of 160 days for cleared devices.

Medical Genetics has by far the highest proportional NSE rate at 42% (8 NSE decisions out of 19 total submissions), though its volume is very small. Among high-volume panels, Microbiology has the most NSE decisions (62 of 7,038 submissions, 0.88%) followed by Neurology (54 of 6,214, 0.87%).

The review panel determines which FDA reviewers evaluate your submission, what technical expertise they bring, and how they have historically interpreted substantial equivalence arguments. Understanding panel-specific NSE patterns, average review times, and predicate device availability is a key part of 510(k) regulatory strategy.