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


Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

IVD symbol final guidance issued: FDA retains recommendation that accompanying glossaries for symbols be included as part of package inserts rather than as separate labeling. However, the 1Nov. 30 guidance on "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use" withdraws a draft proposal to "exercise enforcement discretion if a company used the symbol that represents 'manufacturer' to satisfy...610.64," a section dealing with the name and address of distributors. "Upon reflection, that symbol does not appear applicable to section 610.64," FDA explains in an accompanying Federal Register notice. The device and biologics centers issued the draft version of the document in October 2003, after industry pressed for symbols in lieu of text to aid harmonization efforts and save space (2"The Gray Sheet" Nov. 3, 2003, p. 6)...

Related Content




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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