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

Senate Bill Would Create New Diagnostics Center At FDA

This article was originally published in The Gray Sheet

Executive Summary

A bill under development by Sen. Orrin Hatch, R-Utah, would carve out a new center at FDA for regulating all advanced diagnostics, according to stakeholders familiar with recent versions of the draft legislation.

You may also be interested in...



Senators Circulate Plan For Stand-alone FDA Diagnostics Center, ‘In Vitro Clinical Test’ Rules

Senators are drafting legislation to create a stand-alone FDA Center to oversee diagnostics, including IVDs and LDTs, under a framework distinct from current medical device regulations.

Senators Circulate Plan For Standalone FDA Diagnostics Center, ‘In Vitro Clinical Test’ Rules

Senators are drafting legislation to create a standalone FDA Center to oversee diagnostics, including IVDs and LDTs, under a framework distinct from current medical device regulations.

CDRH In 2012: More Pilots, Guidances And Regs

The device center plans to finalize all the 510(k) program guidances it issued last year, among a boatload of 2012 priorities. Many of this year's top goals spring from the 510(k) and “science in regulatory decision making” reform programs that commanded attention in 2011.

Related Content

Latest News
See All
UsernamePublicRestriction

Register

MT030010

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