Home » Blog » FDA Moving Ahead with Rulemaking On Lab Developed Tests Without Waiting for Congress: BioWorld

FDA Moving Ahead with Rulemaking On Lab Developed Tests Without Waiting for Congress: BioWorld

April 26, 2023 Decoteau Wilkerson

FDA

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced fromMedTech Dive, titled“FDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld”– originally authored byNick Paul Taylorand published on March 2, 2023.

FDA Moving Ahead with Rulemaking On Lab Developed Tests Without Waiting for Congress: BioWorld

FDA headquarters in White Oak, Maryland. Sarah Silbiger/Getty Images via Getty Images

Dive Brief:

  • The U.S. Food and Drug Administration is “moving forward with rulemaking” on laboratory developed tests (LDTs) without waiting for new powers from Congress, a senior FDA official said at an industry conference.
  • Elizabeth Hillebrenner said on a panel Wednesday that the agency cannot “just stand by” given the perceived public health problem created by LDTs and the failure of Congress to pass legislation.
  • The FDA has yet to set a timeline for LDT rulemaking or provide a close look at its plans, Hillebrenner said, noting that the agency will follow a three-tier risk framework, but giving few other details.

RELATED:Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part I

Dive Insight:

Lawmakers have been trying to pass LDT legislation for years. An earlier form of the Verifying Accurate Leading-Edge IVCT Development (VALID) Act wasintroducedto Congress in 2018. Key aspects of the draft advanced as part of the FDA’s user fee package last year, only to becutfrom the final version. A push to pass the VALID Act as standalone lawfell shortlate last year.

The FDAidentified需要重新考虑其政策执行说cretion for LDTs in 2010, reflecting the increasing complexity and risks of the tests, and shared a discussion paper in 2017. However, the paper is not enforceable.

RELATED:2023 Predictions for Medical Device Product Development

Legislation would clarify the FDA’s authority to regulate LDTs and give the agency new powers, but in the ongoing absence of action from Congress, work is now advancing under the current statutory authority. Hillebrenner, associate director for scientific and regulatory programs at the FDA’s Center for Devices and Radiological Health,outlinedthe situation at an American Clinical Laboratory Association event.

In comments reported byBioWorld, Hillebrenner noted that FDA Commissioner Robert Califf “has already said all options are on the table, including rulemaking, and we are moving forward.” The FDA continues to support legislation such as the VALID Act that provides a regulatory framework in line with modern diagnostics but is no longer willing to wait on Congress to address the problems posed by LDTs, she said.


Previous Article
What is a Trial Master File in the Medical Device Industry?
What is a Trial Master File in the Medical Device Industry?

What is a Trial Master File in the Medical Device Industry? A Trial Master File, also known as a TMF, is a ...

Next Article
Introduction to ISO 24089: Your Ultimate Guide to Understanding and Implementing
Introduction to ISO 24089: Your Ultimate Guide to Understanding and Implementing

ISO 24089, developed by the International Organization for Standardization (ISO), is a standard that provid...

Return to Home