Medical Devices

Device Classification Panels

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 SpecialtyRegulation Citation (21CFR)
73AnesthesiologyPart 868
74CardiovascularPart 870
75ChemistryPart 862
76DentalPart 872
77Ear, Nose, and ThroatPart 874
78Gastroenterology and UrologyPart 876
79General and Plastic SurgeryPart 878
80General HospitalPart 880
81HematologyPart 864
82ImmunologyPart 866
83MicrobiologyPart 866
84NeurologyPart 882
85Obstetrical and GynecologicalPart 884
86OphthalmicPart 886
87OrthopedicPart 888
88PathologyPart 864
89Physical MedicinePart 890
90RadiologyPart 892
91ToxicologyPart 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.

Page Last Updated: 06/26/2014
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