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

TMJ decision

This article was originally published in The Gray Sheet

Executive Summary

FDA administrative law judge rules July 6 that Colorado-based TMJ Implants and two executives are liable for civil money penalties of up to $630,000 for not filing 17 adverse event reports. The events were documented in a February 2004 warning letter to the firm, which makes temporomandibular joint prostheses. The company maintains its internal assessment showed the events did not meet the reporting threshold of causing or contributing to a serious injury and appealed the matter to the FDA commissioner before the agency entered a complaint with the administrative court in July 2005 (1"The Gray Sheet" Jan. 1, 2007, p. 4). The case has resulted in pressure on FDA from House Republicans questioning the fairness of the warning letter appeals process based on TMJ's assertions that its plea to the commissioner was short circuited (2"The Gray Sheet" May 7, 2007, p. 7)...

You may also be interested in...



House Republicans Challenge FDA On Warning Letter Appeals Process

Senior House Republicans are challenging FDA on the fairness of its warning letter appeals process in response to an agency dispute with dental device manufacturer TMJ Implants

Judge Will Consider “Serious Injury” Interpretations In FDA MDR Regs

FDA and Colorado-based TMJ Implants will seek resolution to an almost three-year-old dispute over the interpretation of medical device adverse event reporting regulations before an administrative law judge in April

The Race Is On To Launch COVID-19 Antibody Home-Test In The UK

Feature: Public Health England has revealed it is only a week away from approving a COVID-19 antibody test for distribution via Amazon. HBW Insight looks at the race to place the first, government-approved coronavirus home-test on the UK market.

UsernamePublicRestriction

Register

MT025033

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