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

US FDA Panel Takes On Neurological Device Classification

Executive Summary

While the panelists backed FDA recommendations for most devices discussed, they said two might need to be placed in class III so the agency can gather more information.

You may also be interested in...



First EUA In US For OTC Test To Detect COVID-19, Flu, RSV Granted To Labcorp

Agency issued an emergency use authorization to Labcorp for its OTC that detects COVID-19, flu and respiratory syncytial virus.

Senate Bill Establishes Greater Regulatory Oversight Of Lab Developed Tests

Draft legislation out of the US Senate Health, Education, Labor and Pensions (HELP) Committee gives the FDA authority to regulate certain in vitro diagnostics known as laboratory developed tests.

Watchdog Calls On FDA To Set Policy For Use Of Unauthorized Tests In Public Health Emergencies

The US Government Accountability Office reviewed how the FDA reviewed and monitored COVID-19 tests during the pandemic and found room for improvement. One particular concern was the lack of a straightforward policy on when enforcement discretion would be used. 

Topics

UsernamePublicRestriction

Register

MT144025

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