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

In Brief: Microbiology Devices Panel

This article was originally published in The Gray Sheet

Executive Summary

Microbiology Devices Panel: FDA advisory panel unanimously votes (5-0) in favor of downclassification of automated short-term incubation cycle antimicrobial susceptibility devices from Class III to Class II at a Feb. 13 meeting in Rockville, Maryland. BioMerieux Vitek requested the downclassification in a petition submitted to the agency on July 24, 1997 ("The Gray Sheet" Aug. 18, I&W-6). Special controls recommended by the panel include an updated version of FDA's "Review Criteria for the Assessment of Antimicrobial Susceptibility Devices"...

You may also be interested in...



EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments

While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.

US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail

Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.

UsernamePublicRestriction

Register

ID1125791

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

Cancel