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 In this section:

        Medical Devices

Device Advice: Comprehensive Regulatory Assistance

                        
                


                Overview of Device Regulation
          How to Study and Market Your Device
          Postmarket Requirements (Devices)
          Quality and Compliance (Medical Devices)
          Human Factors and Medical Devices
          Medical Device Databases
          Guidance Documents (Medical Devices and Radiation-Emitting Products)
          Data Standards and Terminology Standards for Information Submitted to CDRH
          Reprocessing of Reusable Medical Devices: Information for Manufacturers
          Importing and Exporting Medical Devices
          Unique Device Identification System (UDI System)
          IVD Regulatory Assistance
          Contact Us – Division of Industry and Consumer Education (DICE) Home
          Medical Devices
          Device Advice: Comprehensive Regulatory AssistanceMedical Devices Device Advice: Comprehensive Regulatory Assistance
  	
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    PrintWelcome to Device Advice, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) web page for comprehensive regulatory education. Device Advice is CDRH's premier text-based resource that explains medical device laws, regulations, guidances, and policies, across the entire product lifecycle.
Sub-Topic Paragraphs
          Bringing a Device to MarketIs it a Medical Device?Medical Device User FeesHow to Study and Market Your DeviceDevice Registration and Listing
          Search Medical Device DatabasesAll Medical Device DatabasesFind FDA Guidance DocumentsFind Medical Device FormsCode of Federal Regulations (CFR)
          ResourcesWebinar Feature Graphic

                    Webinar
            CDRH hosts webinars and calls to educate stakeholders on guidances and other topics related to the regulation of medical devices and radiation-emitting products. This web page contains information about such events, both past and upcoming.
          
          Photo of Joseph Tartal, CDRH-DICE

                    CDRH Learn
            CDRH Learn is our multi-media educational resource, featuring learning modules that address medical device laws, regulations, guidances, and policies, across the entire product life cycle.
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              Contact Us
        
      
  Contact Point
              Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
      
	DICE@fda.hhs.gov
      
	
	(800) 638-2041
      
		
		
            (301) 796-7100
      
		
	
		
	Hours Available

	
		Office of Communication and Education

                                                                                  Content current as of:
      06/22/2023Device Advice: Comprehensive Regulatory Assistance                
                          

                        


                        Overview of Device Regulation
          How to Study and Market Your Device
          Postmarket Requirements (Devices)
          Quality and Compliance (Medical Devices)
          Human Factors and Medical Devices
          Medical Device Databases
          Guidance Documents (Medical Devices and Radiation-Emitting Products)
          Data Standards and Terminology Standards for Information Submitted to CDRH
          Reprocessing of Reusable Medical Devices: Information for Manufacturers
          Importing and Exporting Medical Devices
          Unique Device Identification System (UDI System)
          IVD Regulatory Assistance
          Contact Us – Division of Industry and Consumer Education (DICE)
 
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