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 Should Cite Regulatory Imperative When Narrowing 510(k) Claims – Cook

This article was originally published in The Gray Sheet

Executive Summary

FDA should consult with a three-person "supervisory" panel in deciding whether to narrow a proposed indication statement for 510(k) devices, Cook Group, Inc. suggests in March 4 comments to HHS Secretary Thompson's regulatory reform advisory committee

You may also be interested in...



FDAMA In Action? ODE Shows Progress On IDE Supplements, Five-Day Notice

The Center for Devices and Radiological Health is addressing industry concerns over FDA's handling of increasing numbers of investigational device exemption supplements and use of the agency's five-day notice program for clinical trial changes

Atlas Biomed Unlocking Japan’s OTC Market With Direct-To-Consumer DNA And Microbiome Tests

Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus. 

UsernamePublicRestriction

Register

OM003971

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