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 In this section:

                Classify Your Medical Device

Classify Your Medical Device

                        Does the Product Emit Radiation?
          How to Determine if Your Product is a Medical Device
          Medical Device Accessories
          Device Classification Panels
          Class I and Class II Device Exemptions
          Product Code Classification Database
          Reclassification Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          Overview of Device Regulation
          Classify Your Medical Device
          Device Classification PanelsClassify Your Medical Device Device Classification Panels
  
  	
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    PrintWhat 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 86874
			Cardiovascular
			Part 87075
			Chemistry
			Part 86276
			Dental
			Part 87277
			Ear, Nose, and Throat
			Part 87478
			Gastroenterology and Urology
			Part 87679
			General and Plastic Surgery
			Part 87880
			General Hospital
			Part 88081
			Hematology
			Part 86482
			Immunology
			Part 86683
			Microbiology
			Part 86684
			Neurology
			Part 88285
			Obstetrical and Gynecological
			Part 88486
			Ophthalmic
			Part 88687
			Orthopedic
			Part 88888
			Pathology
			Part 86489
			Physical Medicine
			Part 89090
			Radiology
			Part 89291
			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

Premarket Notification 510(k)
	Premarket Approval (PMA)
	Class I / II Exemptions
	Humanitarian Device Exemption

                                                                                  Content current as of:
      08/31/2018
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsTopic(s)
			  FDA Activities
				    				       				    				       Application & ApprovalsClassify Your Medical Device

          
                        Does the Product Emit Radiation?
          How to Determine if Your Product is a Medical Device
          Medical Device Accessories
          Device Classification Panels
          Class I and Class II Device Exemptions
          Product Code Classification Database
          Reclassification
 
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