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GUIDANCE DOCUMENT

Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) September 1989

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.

This publication explains label and labeling regulations and requirements for medical devices. The Food and Drug Administration has many labeling-related requirements to help assure that devices are used safely and effectively, including, but not limited to, provisions on misbranding in Section 502 of the Food, Drug, and Cosmetic (FD&C) Act. This publication explains such topics as advertising matter as labeling, what is false and misleading labeling, how prominent labeling information must be, what information must appear on containers as well as outside labels, adequate directions for use, prescription device requirements, and special labeling for particular devices or types of devices and uses.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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