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).
- 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 1010
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, 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.
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 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)
- Alternative to Certain Prescription Device Labeling Requirements: Guidance for Industry (PDF - 22KB)
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)