Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

CDRH Offers Primer On Its Guidance Priority-Setting Process

This article was originally published in The Gray Sheet

Executive Summary

The device center’s priorities for guidance development shift throughout the year based on evolving urgencies and mandates, and are not fully reflected on the public website. CDRH described its process at a meeting this month, and heard guidance wish lists for industry and other stakeholders.

You may also be interested in...



Draft Guidance Docs Should Be Transitory, Industry Insists

Device industry advocates stressed to CDRH during a meeting last week that draft-guidance documents need to more routinely be finalized or withdrawn in an expedited manner, and that agency staffers must resist using the out-for-comment document as if they are settled policy.

Minute Insight: Enovis Buys Lima To Great Billion-Dollar Recon Business

Enovis has agreed to buy Italian orthopedic implant manufacturer Lima from a private equity firm for €800m – about $845m. The deal will expand Enovis’ presence in the fast-growing international extremities market and improve its manufacturing and innovation facilities.

Contingency Planning: Guidance Doc Details Handling Clinical Trials During Emergencies

The agency urges sponsors to keep patient safety “first and foremost” in determining how to continue a clinical trial during a natural disaster, public health emergency, or other crisis.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT033079

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