Rx Only Symbol On Medical Devices

Summary: Use of Symbols in Labeling (Final Rule) | FDA

https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/summary-use-symbols-labeling-final-rule

FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices. Regulatory...

Using Symbols to Convey Information in Medical Device …

https://www.fda.gov/news-events/fda-voices/using-symbols-convey-information-medical-device-labeling

Symbols Commonly Used in Medical Device and …

https://www.draeger.com/Library/Content/Draeger-website_Symbols_FDA-Guidance_Rev-00.pdf

1. Rx only Caution: Federal law restricts this device to sale by or on the order Use of the “Rx only” symbol as an alternative to the prescription device labeling statement. FDA …

Medical Device Labeling: Rx Only - Elsmar Cove Quality …

https://elsmar.com/elsmarqualityforum/threads/medical-device-labeling-rx-only.43595/

This is a risk reduction measure. If so, "Rx Only" needs to be on all package labels even if a regulatory requirement for it does not exist. I define "Rx Only" (with …

801.109 - Prescription devices. - LII / Legal Information …

https://www.law.cornell.edu/cfr/text/21/801.109

(1) The symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the …

eCFR :: 21 CFR 801.109 -- Prescription devices.

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-D/section-801.109

( 1) The symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the …

Symbols to be used on labelling (ISO 15223) …

https://www.bsigroup.com/globalassets/meddev/localfiles/it-it/webinars/bsi-md-symbols-and-information-to-be-provided-by-the-manufacturer-webinar.pdf

symbol used in medical device labelling graphical representation appearing on the label (3.3) and/or associated documentation of a medical device that communicates …

What Does The Rx Only Symbol Mean? - Caniry

https://www.caniry.com/what-does-the-rx-only-symbol-mean/

A “restricted device” is a device that can only be sold, distributed or used upon the order of an authorized healthcare provider, generally referred to as prescription …

eCFR :: 21 CFR Part 801 -- Labeling

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801

(a) Statements of all conditions, purposes, or uses for which such device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or …

CFR - Code of Federal Regulations Title 21 - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=801.109

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 801.109 Prescription devices. A device which, because …