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

ReGen Says Lack Of FDA Sports Med Specialists Blocks Its Knee Product

This article was originally published in The Gray Sheet

Executive Summary

ReGen Biologics is convinced that a lack of sports medicine specialists at FDA's orthopedic devices review branch is to blame for the agency's refusal to grant 510(k) clearance for its knee cartilage repair product

You may also be interested in...



Device Center Discord: 510(k) Review Process Is Flash Point At CDRH

Details trickling into the public sphere about CDRH's device review process reveal heightened tension between reviewers and management over the proper response to a 510(k) submission

Device Center Discord: 510(k) Review Process Is Flash Point At CDRH

Details trickling into the public sphere about CDRH's device review process reveal heightened tension between reviewers and management over the proper response to a 510(k) submission

Third Time Is The Charm For ReGen’s Knee Repair Collagen Scaffold

ReGen Biologics plans a February U.S. launch of its Menaflex collagen knee cartilage repair product at the 2009 American Academy of Orthopedic Surgeons meeting in Las Vegas now that FDA has signed off on the product after several years of resistance

Related Content

UsernamePublicRestriction

Register

MT025319

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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