News & Analysis as of

Laboratory Developed Tests

FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

Health Law Insights: February Newsletter

by Roetzel & Andress on

ALERT: Technical Noncompliance with HIPAA Can Lead to Big Penalties- As discussed in prior client alerts, the Office of Civil Rights (OCR), the agency charged with HIPAA enforcement, has increased HIPAA compliance...more

FDA Hits “Pause” on Regulation of LDTs

by Foley & Lardner LLP on

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper). The Discussion Paper follows FDA’s late 2016 announcement that,...more

FDA's 'Conversation Starter' Paper Suggests Altered Approach for Laboratories

by Polsinelli on

While a new U.S. Food & Drug Administration discussion paper neither serves as legal guidance nor effects any immediate policy changes, its issuance does suggest that the FDA may take a less stringent approach to regulating...more

FDA Outlines Substantially Revised ‘Possible Approach’ to the Regulation of Laboratory-Developed Tests

by McDermott Will & Emery on

On January 13, 2017, the US Food and Drug Administration (FDA) posted a “discussion paper” in which the agency outlines a substantially revised “possible approach” to the oversight of laboratory-developed tests (LDTs). The...more

FDA Issues Discussion Paper on LDTs

by King & Spalding on

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more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

by Reed Smith on

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

by Cooley LLP on

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

by Ropes & Gray LLP on

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

by Cooley LLP on

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

by Reed Smith on

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

by Morgan Lewis on

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

by Alston & Bird on

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

by Foley & Lardner LLP on

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

by Mintz Levin - ML Strategies on

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?

by Foley & Lardner LLP on

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

by Mintz Levin on

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

by Reed Smith on

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

by Reed Smith on

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

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