Medtech Insight is part of the Business Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

In Brief: Infant radiant warmer downclassification

This article was originally published in The Gray Sheet

Executive Summary

Infant radiant warmer downclassification: FDA completes 11-year classification effort by moving infant radiant warmers from Class III to Class II in a final rule published in the June 19 Federal Register. The notice finalizes an August 1996 proposed rule to downclassify the devices with special controls ("The Gray Sheet" Sept. 2, p. 11). FDA moved to reclassify the devices after the Health Industry Manufacturers Association submitted a reclassification petition in January 1986 that responded to a proposed rule calling for premarket applications or product development protocols for the devices. Special controls for the device include the Association for the Advancement of Medical Instrumentation Voluntary Standard for the Infant Radiant Warmer, a prescription statement and labeling...
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT008273

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

Cancel