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

2021 Forecast Includes Rise In FDA Enforcement Actions

Executive Summary

The Biden administration may take a heavier hand with manufacturers than we saw in recent years, attorneys say.

You may also be interested in...



QA/RA Outlook 2021: 4 Hotspots To Watch, From ‘Hybrid’ US FDA Inspections To QSR Harmonization

Two QA/RA experts highlight hot-button topics that quality assurance and regulatory affairs professionals should keep an eye on in the medtech space this year.

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.

FDA Stops Granting EUAs For Lab Developed Tests, Denying LDT Makers PREP Act Liability Protections

The tug of war between the US HHS and the FDA over laboratory developed tests took a surprising turn on 7 October when the agency declared that it will no longer issue emergency use authorizations for LDTs. That means unapproved COVID-19 tests that come to market without an EUA won’t be covered under the PREP Act, which protects makers of pandemic-fighting products from lawsuits.

Related Content

Topics

UsernamePublicRestriction

Register

MT143413

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