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

Heparin catheter flush finds a home at CDRH

This article was originally published in The Gray Sheet

Executive Summary

Effective Oct. 16, the device center will assume primary responsibility for the regulation of heparin lock-flush solution products, some of which had been under the purview of the Center for Drug Evaluation and Research. The transfer of the combination product to CDRH reflects FDA's determination that the primary mode of action is that of the device, which is used to keep intravascular catheters open and prevent blood from clotting. Heparin lock-flush solution products will now be considered 510(k) products, and must comply with the device Quality System Regulation. FDA will not assess any application user fees for the administrative transfer...

You may also be interested in...



Claim That Supplement Boosts Children’s Focus Could Spur FTC Attention

Creekside Natural Therapeutics might hear from the FTC after failing to show in an industry self-regulation forum that it would correct misleading claims for its Focused Mind Jr. supplement promoted as an alternative to ADHD drugs.

Deal Watch: Novo Nordisk, Fauna To Explore Hibernation To Treat Obesity

A collaboration between Novo and Fauna will look at animal hibernation and genetic sequencing for hints toward novel therapies for obesity. Pfizer will use Insilico’s machine learning technology in target validation.

Scrip’s Rough Guide On The State Of RNAi

The introduction of gene therapies has been the highest-profile new modality to reach the market, but new RNA-based therapeutics hold significant potential and could be more accessible for patients. Scrip reviews the leading drug developers in this space.

UsernamePublicRestriction

Register

MT023897

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