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        Device Advice: Comprehensive Regulatory Assistance

Guidance Documents (Medical Devices and Radiation-Emitting Products)

                        
                Cross-Center Final Guidance
          Recent Final Medical Device Guidance Documents
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          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          Guidance Documents (Medical Devices and Radiation-Emitting Products)Device Advice: Comprehensive Regulatory Assistance Guidance Documents (Medical Devices and Radiation-Emitting Products)
  	
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**What is guidance?**

Guidance documents are prepared for the FDA’s staff, regulated industry, and the public to describe the FDA’s interpretation of or policy on a regulatory issue. Guidance documents include, but are not limited to, documents that relate to:

the design, production, labeling, promotion, manufacturing, and testing of regulated products
	the processing, content, and evaluation or approval of submissions
	inspection and enforcement policiesGuidance documents do not establish any rights for any person and is not binding on FDA or the public. An alternative approach may be used if it satisfies the requirements of the applicable statue and regulations.

Additional Information

Search for official FDA guidance documents and other regulatory guidance for all topics
	CDRH Proposed Guidance Development
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	Radiation-Emitting Products Guidance DocumentsContact FDA

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(301) 796-7100DICE@fda.hhs.gov

**Information-Medical Devices / Radiation Products**Division of Industry and Consumer Education
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			  			     			  			     Radiation-Emitting ProductsGuidance Documents (Medical Devices and Radiation-Emitting Products)                
                          

                        Cross-Center Final Guidance
          Recent Final Medical Device Guidance Documents
          Draft Medical Device Guidance
          CDRH Proposed Guidance Development
          Class II Special Controls Documents
          Withdrawn or Expired Guidance
          Tips for Submitting Comments on CDRH Guidance Documents
 
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