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Alternative to Certain Prescription Device Labeling Requirements Guidance for Industry January 2000

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

CDRH would like to minimize the burden on manufacturers, repackers, relabelers and distributors that face a variety of labeling requirements and changes. Therefore, CDRH, in its enforcement discretion, does not intend to object to the use of the statement “Rx only” as an alternative to the prescription device labeling statement “Caution: Federal law restricts this device to sale by or on the order of a (licensed healthcare practitioner).” It is important to note that FDA intends to exercise its enforcement discretion only for the labeling alternative “Rx only.” “Only” needs to immediately follow “Rx.” However, the symbol statement “Rx only” does not necessarily need to be bracketed in quotation marks, and the word “only” may appear in upper or lower case letters, for example, Rx only, Rx Only, or Rx ONLY.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.