Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) September 1989
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Guidance Issuing OfficeCenter 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.
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:
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.