Scrip 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

AdvaMed objects to proposal to create new class for medium-risk devices

This article was originally published in RAJ Devices

Executive Summary

US medtech industry association AdvaMed has objected to a proposal by the Food and Drug Administration to create a new category of moderate-risk devices, Class IIb. The category would be added to the agency's current device classification rules and its aim would be to clarify upfront that the marketing submissions of devices in this category would have to be supported by additional clinical and/or manufacturing data1.

You may also be interested in...



Canada Allows Exceptional Drug, Device Imports To Tackle COVID-19 Shortages

Medical products that do not fully comply with Canadian requirements but are manufactured according to comparable standards are being allowed into the country to deal with COVID-19-related shortages.

Canada Allows Exceptional Drug, Device Imports To Tackle COVID-19 Shortages

Medical products that do not fully comply with Canadian requirements but are manufactured according to comparable standards are being allowed into the country to deal with COVID-19-related shortages.

Global Pharma Guidance Tracker – March 2020

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

UsernamePublicRestriction

Register

SC096300

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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