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

Burgess Still Wants to Limit FDA LDT Oversight

This article was originally published in The Gray Sheet

Executive Summary

Despite failing to move on a bill to restrict FDA oversight of lab developed tests (LDT) or reintroducing the bill in recent sessions, Rep. Michael Burgess, R-Texas, says he still supports the idea and is still working on trying to limit the agency's authority.

You may also be interested in...



FDA Releases LDT Regulatory Framework, Notification Draft Guidances

Two promised draft guidances on FDA’s framework for regulating laboratory developed tests and notification and medical device reporting requirements for LDTs have been posted. The agency wants swift notification from labs for most available LDTs once a framework is finalized.

Flurries Of New Bills Advance Device Industry Interests In Congress

The first legislative salvos were launched last week in a battle that is sure to escalate in conjunction with device user fee reauthorization efforts next year.

Oxford/AstraZeneca Vaccine Shows 70% Efficacy As Company Prepares Approval Filings

Topline results with AZD1222 have shown a lower efficacy rate than the Pfizer and Moderna vaccines, but a subgroup receiving a half-dose in their first injection showed a 90% efficacy result.

Topics

UsernamePublicRestriction

Register

LL1134786

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