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

Manufacturers must respond within 30 days

Executive Summary

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.

You may also be interested in...



One-Two Punch Of HHS Rules On Guidance Docs, Regs Will ‘Tie Hands’ Of Biden Admin: Expert

Two new rules put forward by the US HHS could have a chilling effect on future guidance documents and regulations drafted by the FDA and the 27 other agencies and offices the HHS oversees, a policy expert says. This and other stories topped our list of most-read US regulation, policy, quality control and compliance articles in December.

On-Site Inspections Of US Device Makers Plummet 93% As FDA Scrambles For Virtual Solutions

A sharp decline in the number of in-person facility inspections has forced the FDA to consider creative techniques for remotely evaluating manufacturer compliance during the COVID-19 pandemic. This and other stories topped our list of most-read Medtech Insight articles in November.

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.

Related Content

Topics

UsernamePublicRestriction

Register

LL1135544

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