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

FDA MDR COST ESTIMATES EXPECTED TO BE FOCUS OF REP. UPTON'S NEXT ROUND OF QUESTIONS ON MDR RULE; AGENCY STANDS BY $600 PER-ESTABLISHMENT FIGURE

This article was originally published in The Gray Sheet

Executive Summary

Rep. Fred Upton (R-Mich.) is expected to continue scrutinizing FDA's cost estimates for complying with the medical device reporting rule. Upton is drafting a letter to the agency that will express dissatisfaction with several responses FDA gave to a series of MDR-related questions posed by the legislator in May. One of the likely focal points of the upcoming letter will be the agency's defense of its cost estimates.

You may also be interested in...



QUOTED. 22 January 2020. Steve Niedelman.

Steve Niedelman of the law firm King & Spalding gave manufacturers a few words of advice when prepping their so-called front rooms, where US FDA investigators do the majority of their work during facility inspections. See what he said here.

FDA’s Follow-Up Sunscreen Trial Shows More Of The Same: Absorption Of All Tested UV Filters

The FDA emphasizes that findings from its second, more extensive clinical study on the absorption potential of sunscreen active ingredients are not in themselves signals that the UV filters are unsafe. However, they portend heavy work ahead for industry if the ingredients are to remain GRASE and available for use in OTC sunscreen drug products stateside.  
 

Health Sector On High Alert As Wuhan Coronavirus Spreads

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”

UsernamePublicRestriction

Register

MT006258

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