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 In this section:

        Medical Device Safety

Emergency Situations (Medical Devices)

                        
                Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Health Care Providers, Device Manufacturers, and Distributors


                Coronavirus (COVID-19) and Medical Devices
          Emergency Use Authorizations for Medical Devices
          Monkeypox (mpox) and Medical Devices Home
          Medical Devices
          Medical Device Safety
          Emergency Situations (Medical Devices)Medical Device Safety Emergency Situations (Medical Devices)
  	
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    PrintSome medical devices are used to prevent or treat emergency situations.  These include diagnostic equipment and tests, personal protective equipment such as masks or gloves, and surgical tools and supplies.

Other medical devices have no bearing on the emergency, but may be adversely affected by conditions such as loss of power, moisture, or contamination.

On Feb. 21, 2013, the FDA issued a Federal Register notice requesting comments from the public on three scenarios related to medical devices and extreme weather, such as hurricanes, floods, lightning storms, earthquakes, and fires. Extreme weather events and natural disasters can interfere with the manufacturing, shipping, storage, or use of marketed devices, which may lead to concerns with their safety or effectiveness. The FDA will use this information to help determine how it can optimize its current regulatory framework to address risks and vulnerabilities to the manufacturing chain resulting from extreme weather conditions. Future steps may be identified to help industry mitigate or better tolerate challenges to the manufacturing chain as a result of extreme weather conditions. To submit comments, please see Federal Register Notice: Extreme Weather Effects on Medical Device Safety and Quality.

Related Links

Federal Register: Extreme Weather Effects on Medical Device Safety and Quality
	Federal Register: Device Good Manufacturing Practice Advisory Committee; Notice of MeetingOther Resources

Emergency Preparedness and Response
	Personal Protective Equipment for Infection Control

                                                                                  Content current as of:
      05/12/2023
                  
                   
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsEmergency Situations (Medical Devices)                
                          

                        Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Health Care Providers, Device Manufacturers, and Distributors


                        Coronavirus (COVID-19) and Medical Devices
          Emergency Use Authorizations for Medical Devices
          Monkeypox (mpox) and Medical Devices
 
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