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

DePuy Weighs HDE Costs; FDA Stresses Data Options Over Statutory Limits

This article was originally published in The Gray Sheet

Executive Summary

The Center for Devices & Radiological Health is encouraging greater use of humanitarian device exemptions by inviting manufacturers to submit alternative forms of data to support submissions

You may also be interested in...



Rare Diseases Working Group Should Address CLIA Lab Participation – SACGT

The Rare Diseases Working Group of the HHS Secretary's Advisory Committee on Genetic Testing should look at ways to shift testing for rare diseases from research labs to CLIA-certified clinical labs, the committee concluded

FDA Plugs HDE Program, Shows Flexibility With Population, Cost Criteria

FDA is seeking broader use of the humanitarian device exemption program by encouraging dialogue with manufacturers about HDE requirements for patient population and cost

Aducanumab Review: Looking For Precedents – Long Ago And Far Afield

The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.

UsernamePublicRestriction

Register

OM004559

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