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

UsernamePublicRestriction

Holder Of EUA Gets FDA Warning Letter For Not Satisfying MDR Reporting Requirements

Executive Summary

Battelle Memorial Institute, an N95 respirator decontamination system maker, has been back-and-forth with regulators about its Medical Device Reporting protocols, which the US FDA says is lacking. Battelle was granted an emergency use authorization by the agency for its CCDS Critical Care Decontamination System to decontaminate N95 respirators back in March.

You may also be interested in...



FDA Sets New Restrictions For Authorized N95 Decontamination Systems

After reviewing real-world data, the US agency says the decontamination systems should only be used for compatible facemasks and should not be used to clean a mask more than four times.

Battelle Decontamination System Gets EUA To Fight Respirator Shortage

The US FDA has issued an emergency use authorization for a Battelle decontamination system to clean N95 masks, which are currently facing a shortage due to the COVID-19 pandemic. The company says it can clean up to 80,000 respirator masks a day from participating health care providers.

Massive Family Dollar Rat Infestation Leads To Multi-State Recall

The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT142862

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