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

In Brief: Device remarketing

This article was originally published in The Gray Sheet

Executive Summary

Device remarketing: Comments on FDA's plans to revise its policies for regulating device remarketers are due by March 23, the agency says in a Dec. 23 Federal Register notice. The notice includes definitions of refurbishers, "as is" remarketers and servicers, and FDA seeks input on whether it should propose the definitions either in guidance or regulation. The definitions all include the criteria that the company does not "significantly change the finished device's performance or safety specifications or intended use." In addition, FDA is reevaluating the application of labeling, manufacturing, reporting and other requirements to remarketers. The agency also is "considering whether to propose rulemaking regarding modified registration, listing, and" good manufacturing practices requirements for remarketers, "or whether to make some or all of these three controls voluntary"...

You may also be interested in...



EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.

Atlas Biomed Unlocking Japan’s OTC Market With Direct-To-Consumer DNA And Microbiome Tests

Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus. 

Hair Supplement Linked To Cases Of Severe Hepatitis In France

France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.

UsernamePublicRestriction

Register

LL1121650

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