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

COVID-19: US FDA’s Hahn Slams The Brakes On Domestic Inspections ‘For The Health And Well-Being Of Our Staff’

“I want to assure the American public that we have full confidence in the safety and quality of the products we all use every day,” agency head Stephen Hahn says

Executive Summary

A little more than a month after it put the kibosh on conducting facility inspections in China, the agency announced late on 18 March that it was suspending routine surveillance audits in the US, too.

You may also be interested in...



COVID-19: FDA Expands Overseas Inspections Freeze Through April

Industry experts advise companies to prepare for paper-based inspection in light of the US FDA's suspended overseas inspections in response to the COVID-19 crisis.

Coronavirus: All FDA Inspections Of Chinese Manufacturing Facilities Come To Screeching Halt

The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.

Quality Should Ride Shotgun As US Auto Makers Rev Engine On Making Ventilators

As American auto giants GM and Ford take the wheel on working with ventilator manufacturers to make the critically needed devices during the COVID-19 pandemic, two longtime quality experts explain where the device and auto companies will find common ground when it comes to quality systems.

Topics

UsernamePublicRestriction

Register

MT126422

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