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

With New Guidance, FDA Says Makers Of Critical Devices Must Report Manufacturing Or Supply Chain Disruptions

Executive Summary

Manufacturers of life-supporting and -sustaining devices – and other critical products used during the ongoing COVID-19 public health emergency – must let the US agency know if they’re expecting a disruption in manufacturing or supply. A new immediately-in-effect guidance document from the FDA explains how.

You may also be interested in...



Revised FDA Guidance Says Makers Of Tests, Hospital Beds, More Should Tell Agency Of Shortages

The US FDA has updated its how-to guide on reporting device shortages during the pandemic with a separate online resource that lists products for which the agency believes notification would be recommended.

Unpacking The $2.2Tn Stimulus Act: Boosts To Medtech And Diagnostics To Fight Coronavirus

A $2.2tn coronavirus stimulus package signed into law by President Trump on 27 March will distribute billions of dollars to federal agencies – including the FDA, the CDC and the FEMA – to hasten approvals of new diagnostics, medical ventilators, respirators and other medtech supplies, conduct more testing of potential COVID-19 patients, and quickly distribute medical supplies where needed most.

Coronavirus Crisis Highlights FDA’s Device Supply Chain Blind Spots

The ongoing COVID-19 crisis has shone a light on the US agency’s inability to clearly see medical device supply chain troubles to help stave off product shortages. Unlike makers of pharmaceuticals and biologics, there’s no requirement for device firms to tell the FDA if there’s a particular event that could lead to a shortage – but that could change thanks to language found in the agency’s fiscal year 2021 budget request.

Topics

UsernamePublicRestriction

Register

MT126707

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

Cancel