federal_register: 00-1407

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00-1407 Guidance for Industry: Alternative to Certain Prescription Device Labeling Requirements; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Alternative to Certain Prescription Device Labeling Requirements." The FDA Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act (the act) to require, at a minimum, that before dispensing, the labels of prescription drug products contain the symbol "Rx only" instead of the textual prohibition "Caution: Federal law prohibits dispensing without prescription." Through this guidance, the Center for Devices and Radiological Health (CDRH) announces that, in its enforcement discretion, it will apply a similar amended standard for labeling of prescription devices. 2000-01-21 2000 1 https://www.federalregister.gov/documents/2000/01/21/00-1407/guidance-for-industry-alternative-to-certain-prescription-device-labeling-requirements-availability https://www.govinfo.gov/content/pkg/FR-2000-01-21/pdf/00-1407.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Alternative to Certain Prescription Device Labeling Requirements." The FDA Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act...

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