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


Washers For Reusable Devices Should Fall Into Class II, Panel Recommends

This article was originally published in The Gray Sheet

Executive Summary

All previously unclassified washers and washer-disinfectors intended for processing reusable medical devices should be formally grouped under Class II for premarket notification submissions, FDA's General Hospital and Personal Use Devices Panel recommended at its Sept. 14 meeting.

You may also be interested in...

FDA Regulatory News In Brief

Device tracking: 1Medical device tracking final rule amending 1993 reg to reflect changes under FDAMA is effective May 9. No revisions are made to the April 25, 2000 proposed rule (2"The Gray Sheet" May 1, 2000, In Brief). The rule "makes no revisions to the regulation's existing system and content tracking requirements, the current obligations of persons other than device manufacturers, such as distributors, records and inspection requirements and existing record retention requirements." A final guidance on medical device tracking was issued Jan. 24, 2000...

QUOTED. 6 April 2020. Bethany Hills.

Diagnostics company Bodysphere had to retract an announcement that it had received an emergency use authorization from the US FDA for a COVID-19 serologic test. See why Bethany Hills, an attorney with law firm Morrison & Foerster, says this may be a cautionary tale for other manufacturers.




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