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


Internal FDA Menaflex Investigation Finds Serious Process Deviations

This article was originally published in The Gray Sheet

Executive Summary

An internal evaluation of FDA's handling of the controversial 510(k) clearance of a knee implant unearthed serious shortcomings in the integrity of the agency's review process, FDA said Sept. 24

You may also be interested in...

People Briefs: HeartWare CMO, New Posts For Former HHS Officials

HeartWare International names Katrin Leadley chief medical officer. Former CMS Deputy Administrator Jonathan Blum to join CareFirst Blue Cross, while former FDA Deputy Commissioner Sharfstein joins Johns Hopkins. Propeller Health taps senior VP for business and client development.

CDRH Plans Update To Procedures For Resolving Review Staff Disagreements

FDA’s device center is responding to input from HHS’ Office of Inspector General, which was outlined in a June 5 report concluding that gaps remain in processes to ensure all relevant scientific opinions are heard within CDRH.

Exit Interview: FDA's Joshua Sharfstein Reflects On Brief But Busy Tenure

FDA Principal Deputy Commissioner Joshua Sharfstein relinquished his post Jan. 7 to become secretary of the Maryland Department of Health and Mental Hygiene.

Related Content


Latest Headlines
See All



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