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Labeling Requirements

• Introduction to Medical Device Labeling
• Additional Labeling Topics
  

Introduction 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).

The 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, of the retain 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

• General Device Labeling Requirements
  
  • Over the Counter (OTC) Devices
  • Exemptions from Adequate Directions for use (Prescription Devices)
  • Other Exemptions
  • Labeling for Specific Devices
  • Misbranding
• In Vitro Diagnostic Device Labeling Requirements
  
• Investigational Device Labeling Requirements
  
• Quality System Regulation Labeling Requirements
  
• Radiation Emitting Device and Product Requirements

General Labeling Guidance Documents

• Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)
  http://www.fda.gov/cdrh/dsma/470.pdf
  
  
• Write it Right
  http://www.fda.gov/cdrh/dsma/897.pdf
  
  
• Device Labeling Guidance #G91-1 (blue book memo)
  http://www.fda.gov/cdrh/g91-1.html
  
  
• Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
  http://www.fda.gov/cdrh/ohip/guidance/1128.html
  http://www.fda.gov/cdrh/ohip/guidance/1128.pdf
  
  
• Guidance on Labeling for Laboratory Tests; Draft
  http://www.fda.gov/cdrh/ode/1352.html
  http://www.fda.gov/cdrh/ode/1352.pdf
  
  
• Human Factors Principles for Medical Device Labeling
  http://www.fda.gov/cdrh/dsma/227.html
  
  
• National Health Related Items Code – NHRIC (similar to NDC code for drugs)
  http://www.fda.gov/cdrh/nhric/nhric.html
  
  
• Electronic Labeling: 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
  http://www.fda.gov/cdrh/mdufma/bluebook/g03-1.html
  http://www.fda.gov/cdrh/mdufma/bluebook/g03-1.pdf
  
  
• Rx Labeling: Alternative to Certain Prescription Device Labeling Requirements
  http://www.fda.gov/cdrh/comp/rxlabeling.html
  http://www.fda.gov/cdrh/comp/rxlabeling.pdf
  

Natural Rubber (Latex) Labeling

• User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide; Guidance for Industry http://www.fda.gov/cdrh/comp/guidance/1212.html
  http://www.fda.gov/cdrh/comp/guidance/1212.pdf
  
  
• FR Notice: Natural Rubber Containing Medical Devices; User Labeling
  http://www.fda.gov/cdrh/dsma/fr93097.html
  
  
• Variance for IVD's - Approval of an Alternative Requirement of the User Labeling Requirements for Devices that Contain Dry Natural Rubber
  http://www.fda.gov/cdrh/comp/ivdpet.html
  http://www.fda.gov/cdrh/comp/ivdpet.pdf

 

Updated April 24, 2003

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