Device Classification Panels
UPDATE: December 5, 2025
The U.S. Food and Drug Administration is requesting public comment on existing medical device accessories that may or may not be suitable for distinct classification in Class I. This request for public comment is a preliminary step to help the FDA identify suitable accessories for distinct classification into Class I and is intended to seek early feedback from groups and individuals outside the Agency. The FDA intends to consider all relevant comments submitted within 90 days, on or before March 5, 2026, to develop a proposal for the distinct classification action.
* After initially issuing the Request for Public Comment, the FDA extended the comment period by 30 days.
What are the Classification Panels
Most medical devices can be classified by finding the matching description of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892. FDA has classified and described over 1,700 distinct types of devices and organized them in the CFR into 16 medical specialty "panels" such as Cardiovascular devices or Ear, Nose, and Throat devices. These panels are found in Parts 862 through 892 in the CFR. For each of the devices classified by the FDA the CFR gives a general description including the intended use, the class to which the device belongs (i.e., Class I, II, or III), and information about marketing requirements. Your device should meet the definition in a classification regulation contained in 21 CFR 862-892.
How to Locate Classification Regulations
| Medical Specialty | Regulation Citation (21CFR) | |
|---|---|---|
| 73 | Anesthesiology | Part 868 |
| 74 | Cardiovascular | Part 870 |
| 75 | Chemistry | Part 862 |
| 76 | Dental | Part 872 |
| 77 | Ear, Nose, and Throat | Part 874 |
| 78 | Gastroenterology and Urology | Part 876 |
| 79 | General and Plastic Surgery | Part 878 |
| 80 | General Hospital | Part 880 |
| 81 | Hematology | Part 864 |
| 82 | Immunology | Part 866 |
| 83 | Microbiology | Part 866 |
| 84 | Neurology | Part 882 |
| 85 | Obstetrical and Gynecological | Part 884 |
| 86 | Ophthalmic | Part 886 |
| 87 | Orthopedic | Part 888 |
| 88 | Pathology | Part 864 |
| 89 | Physical Medicine | Part 890 |
| 90 | Radiology | Part 892 |
| 91 | Toxicology | Part 862 |
Where to Proceed From Classification
If your device requires premarket notification [510(k)] proceed to the Premarket Notification [510(k)] page. For Class I devices exempt from [510(k)] the submission of a [510(k)] and marketing clearance from FDA is not required. If your Class I (or certain class II) device is exempt, subject to the limitations on exemptions, from the 510(k) process, this will be stated in the classification regulation. However, other General Controls such as registration and listing, labeling, and good manufacturing practices apply. If you have a Class III device requiring premarket approval (PMA) proceed to Premarket Approval (PMA) page.