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


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

Executive Summary

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.

You may also be interested in...

No Longer In Short Supply: US FDA Pulls N95s From Shortage List

The US FDA has removed N95s respirator masks from its medical device shortage list, citing increased domestic production.

FDA Wants To Make Permanent COVID-19 Supply Chain Guidance To Prevent Product Shortages

The US agency issued a new draft guidance to require medical device and diagnostics manufacturers and distributors to report supply chain issues in the event of a public health emergency.

FDA Will Fire Off Noncompliance Letters To Firms That Don’t Report Device Shortages, Agency Warns

The US agency says in the latest update to its medical device shortages guidance doc that it’ll send enforcement missives to companies that don’t notify the agency of a “permanent discontinuance or an interruption in manufacturing” of products deemed critical during the COVID-19 pandemic.

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