Laboratory Developed Tests

News & Analysis as of

FDA Issues Discussion Paper on LDTs

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more

FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal

On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is...more

Blog: FDA Issues Discussion Paper on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop...more

21st Century Cures Act Becomes Law

On December 13, 2016, President Obama signed the 21st Century Cures Act (H.R. 34) into law. The act's 312 pages contain a variety of provisions, including nearly $5 billion in funding for scientific research, $1 billion in...more

FDA Indefinitely Delays Action on Regulating Laboratory Developed Tests

On November 18, 2016, the Food and Drug Administration (FDA) notified industry groups that it no longer plans to finalize its draft guidance on laboratory developed tests (LDTs). FDA stated that it intends to work with the...more

Blog: FDA hits the brakes on LDT draft guidance

Last week the Food and Drug Administration (FDA) decided to delay finalizing draft guidance for Laboratory Developed Tests (LDT). First issued in July of 2014, the draft guidance would give FDA regulatory oversight of LDTs. ...more

CMS Schedules Next Meeting of Advisory Panel on Clinical Diagnostic Laboratory Tests for September 12

CMS has announced that the next meeting date of the Advisory Panel on Clinical Diagnostic Laboratory Tests will be September 12, 2016. The meeting is expected to cover...more

FDA Issues Draft Guidance as Part of Precision Medicine Initiative

The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests. On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more

At Long Last, CMS Issues Final Rule for Lab Fee Schedule Changes

Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the...more

Changing Time for Clinical Laboratories

As Bob Dylan wrote, ‘‘The times, they are a-changin’ ’’ While Dylan certainly had larger issues in mind than the state of the clinical laboratory industry, it still is a fair description of what is happening for laboratories...more

Laboratory Developed Tests Emerging in FDA Regulation

Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer,...more

Laboratories – 2015 Year in Review [VIDEO]

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more

Health Care Update - November 2015 #3

Drug Pricing Issues Heat Up Following HHS Forum - Last week, the Department of Health and Human Services (HHS) hosted a forum on prescription drug costs which featured players from every corner of the industry, including...more

FDA Commits to Moving Forward with LDT Regulation

Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that...more

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

CMS, FDA Establishing Interagency Task Force on LDT Quality Oversight

CMS and FDA are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs), which are tests intended for clinical use and designed, manufactured, and...more

FDA, CMS Form Interagency Task Force on LDT Quality Requirements

FDA and CMS have announced that they are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs) -- tests intended for clinical use and designed,...more

23andMe Receives FDA Approval for Genetic Diagnostic Test

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more

Direct-to-Consumer Genetic Test Authorized by FDA

23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more

Highlights and Commentary from the FDA's Public Workshop on Proposed Framework for Regulatory Oversight of Laboratory Developed...

On January 8-9, 2015, the U.S. Food and Drug Administration (FDA) hosted a workshop to solicit public feedback on its proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). As background, the FDA...more

FDA Posts New Materials on Proposed Laboratory Developed Test (LDT) Regulatory Framework

On Friday, October 31, 2014, FDA posted on its website an audio recording, transcript, and slides from its October 23, 2014 webinar discussing the draft guidance document titled “Framework for Regulatory Oversight of...more

Health Headlines: Also in the News - October 2014

On September 30th, the Food and Drug Administration (FDA) released draft guidance concerning the proposed oversight framework for regulating laboratory developed tests....more

FDA Issues Draft Guidance for Regulation of LDTs

On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more

FDA Issues Draft Guidance for Laboratory Developed Tests

For almost 40 years the FDA has regulated in vitro diagnostics (IVDs) as medical devices. An IVD is a reagent, instrument, or system that is intended for the diagnosis of a disease or other condition, including the...more

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