Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Overview of Device Regulation

Device Labeling

                        
                


                General Device Labeling Requirements
          In Vitro Diagnostic Device Labeling Requirements
          Labeling Requirements for Radiation Emitting Devices and Products
          Quality System Regulation Labeling Requirements Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          Overview of Device Regulation
          Device LabelingOverview of Device Regulation Device Labeling
  	
        Share
    Post
    Linkedin

    Email
    PrintIntroduction to Medical Device Labeling

Label vs. Labeling

The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. Labeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR).

General Device Labeling - 21 CFR Part 801

	Use of Symbols - 21 CFR Part 801.15
	In Vitro Diagnostic Products - 21 CFR Part 809
	Investigational Device Exemptions - 21 CFR Part 812
	Unique Device Identification - 21CFR Part 830
	Good Manufacturing Practices - 21 CFR Part 820
	General Electronic Products - 21 CFR Part 1010The Federal Food, Drug and Cosmetic Act (FFDCA) is the law under which the FDA takes action against regulated products. Specifically:

Section 201(k) defines 'label' as a:

'display of written, printed, or graphic matter upon the immediate container of any article...'

	The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper, if any there be, or the retail package of such article, or is easily legible through the outside container of wrapper.'

	Section 201(m) defines 'labeling' as:
	'all labels and other written, printed, or graphic matter
	(1) upon any article or any of its containers or wrappers, or

	(2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

	The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.Advertising

According to an appellate court decision: "Most, if not all advertising, is labeling. The term 'labeling' is defined in the FFDCA as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from the definition printed matter which constitutes advertising."

Additional Labeling Topics

Device Advice Labeling Topics

Investigational Device Labeling Requirements
	Unique Device Identification
	Symbols in LabelingGeneral Labeling Guidance Documents

Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (PDF - 3MB)
	Device Labeling Guidance #G91-1 (Blue Book Memo)
	Guidance on Medical Device Patient Labeling - Final Guidance for Industry and FDA Staff (PDF - 333KB)
	Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities - #G03-1
	November 2004 Medical Devices Technical Corrections Act (MDTCA) Expanded Authority for Electronic Labeling (PDF - 268KB)Natural Rubber (Latex) Labeling

User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide - Guidance for Industry (PDF - 41KB)

                                                                                  Content current as of:
      10/23/2020
                  
                   
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsDevice Labeling                
                          

                        


                        General Device Labeling Requirements
          In Vitro Diagnostic Device Labeling Requirements
          Labeling Requirements for Radiation Emitting Devices and Products
          Quality System Regulation Labeling Requirements
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop