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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Issues First Mass Downclassification Of Preamendments Class III Devices

This article was originally published in The Gray Sheet

Executive Summary

FDA's reclassification of 38 preamendments devices from Class III into Class II cuts to less than 30 the number of pre-1976 Class III devices on which the Center for Devices and Radiological Health has not initiated some regulatory action.

You may also be interested in...



FDA Proposed Rule Trims Preamendments Reclass List By Three

PMAs would be required for indwelling blood oxyhemoglobin concentration analyzers, cardiopulmonary bypass pulsatile flow generators and ocular plethysmographs, according to a 1Nov. 18 FDA proposed rule

FDA Proposed Rule Trims Preamendments Reclass List By Three

PMAs would be required for indwelling blood oxyhemoglobin concentration analyzers, cardiopulmonary bypass pulsatile flow generators and ocular plethysmographs, according to a 1Nov. 18 FDA proposed rule

FDA reclassification proposed rule

Agency is extending comment period for three of 38 pre-1976 devices proposed for reclassification from Class III to Class II. Comments must be submitted 90 days from Nov. 22. Specifically, the action relates to in-dwelling blood carbon dioxide partial pressure analyzers, blood hydrogen ion concentration analyzers, and blood oxygen partial pressure analyzers. Original mass reclassification was published in March 15, 1999 issue of Federal Register (1"The Gray Sheet" March 22, 1999, p. 10). Guidance for premarket 510(k) notification submissions for indwelling blood gas analyzers is released in the Nov. 22 Federal Register. Comments are due by Feb. 20

Related Content

UsernamePublicRestriction

Register

MT011494

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