Medical Devices
Device Classification Panels
- What are the Classification Panels
- How to Locate Classification Regulations
- Where to Proceed From Classification
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
868 Anesthesiology
870 Cardiovascular
862 Clinical Chemistry and Clinical Toxicology
872 Dental
874 Ear, Nose, and Throat
876 Gastroenterology and Urology
878 General and Plastic Surgery
880 General Hospital and Personal Use
864 Hematology and Pathology
866 Immunology and Microbiology
882 Neurology
884 Obstetrical and Gynecological
886 Ophthalmic
888 Orthopedic
890 Physical Medicine
892 Radiology
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.
Market submission options