Device Classification Panels

Device Classification Panels | Medical Device Consultants | Regulatory Doctor

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.

Market submission options

Device Advice: Comprehensive Regulatory Assistance

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