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: IVD Triage

This article was originally published in The Gray Sheet

Executive Summary

IVD Triage: Additions to FDA's Tier I category of in vitro diagnostics scheduled to take effect June 1, according to FDA's Division of Clinical Laboratory Devices. The agency says that as a result of the triage process, the number of Tier I IVDs, which receive a simplified, administrative review, has been increased by 20% in the Clinical Chemistry Branch, 20% in the Microbiology Branch, and 14% in the Immunology Branch. There is no change in the number of Tier I IVDs in the Hematology Branch. FDA gathered input from the public, industry and healthcare professionals on its triage process at an Oct. 30 workshop in Rockville, Maryland ("The Gray Sheet" Nov. 6, 1995, p. 8)...

You may also be interested in...



Unilever Hit With Class Action Over Mercury-Laced Pond’s Cream Originating In Mexico

According to the plaintiff, Unilever’s Pond’s Rejuveness Anti-Wrinkle Cream is defective insofar as tested product has been found to contain unlabeled mercury, constituting negligence that has resulted in user injuries. The plaintiff seeks certification of a transnational class and compensatory and punitive damages, among other relief.

HBW Product Launches: New Chapter Collagen, Alkamind Acid-Kicking, GNC China, Tetra Bio Canada, More

GNC, Harbin launch supplements in China following regulatory approval; Bee Gone expands with allergy swabs; Bed, Bath & Beyond expands distribution of CBDMedic personal care products promoted by Rob Gronkowski; Tetra Bio has Canadian OK For hemorrhoid and pain relief OTCs, US and European pending; Agrozen offers Urban Daze CBD products; New Chapter portfolio expansion also includes fermented vitamins, elderberry supplements and magnesium; and Alkamind’s Acid-Kicking Coffee Alkalizer creamers help neutralize acid from coffee.

Daraprim Drug Pricing Suit Against Shkreli And Vyera May Signal Future FTC Actions

In joint complaint, the FTC and New York Attorney General allege scheme to block generic Daraprim and maintain exorbitant list price; they cite hundreds of emails the incarcerated Shkreli has exchanged with co-defendant in last six months.

UsernamePublicRestriction

Register

MT005972

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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