Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


"Rx only" labeling

This article was originally published in The Gray Sheet

Executive Summary

Prescription device labeling would be allowed to state "Rx only" in place of the currently required legend: "Federal law restricts this device to sale by or on the order of a [type of licensed practitioner]," under guidance currently being drafted, agency staffers say. The change, which the FDA Modernization Act allowed for drugs, was advocated for devices in a March 1 citizen petition filed on behalf of the Contact Lens Institute. The Rx symbol facilitates "a less cluttered label and international uniformity and simplicity," the petition states. FDAers note that the labeling change likely would not apply to in vitro diagnostic devices, which are subject to separate regulation

You may also be interested in...

"Rx only" labeling

In vitro diagnostics are included under guidance issued Jan. 21 that allows companies to use the words "Rx only" on labels in place of the statement "Caution: Federal law prohibits dispensing without prescription." Inclusion of IVDs had previously been in question (1"The Gray Sheet" July 19, In Brief)

Sandoz Denosumab Biosimilar Progressing Faster Than Anticipated

Sandoz announced more than a year ago that its GP2411 biosimilar denosumab candidate had entered the clinic. Management provided an update on its progress at the recent Virtual Meet Novartis Management Investor Event.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts