Antoinette Konski on Laboratory Developed Tests

Ensuring Accuracy and Trust in Laboratory Developed Tests: FDA's Final Rule

Personalized or precision medicine relies on accurate diagnostic tests. The U.S. Food and Drug Administration’s (FDA) recent final rule now explicitly designates Laboratory Developed Tests (LDTs) as devices under the Federal...more

6/26/2024 / Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests

FDA Hits “Pause” on Regulation of LDTs

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

2/17/2017 / Diagnostic Tests , Discussion Draft , Food and Drug Administration (FDA) , Laboratory Developed Tests

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

2/24/2015 / 23andMe , Clinical Laboratories , Food and Drug Administration (FDA) , Genetic Testing , Laboratory Developed Tests , Medical Devices

FDA Issues Draft Guidance for Regulation of LDTs

On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more

10/6/2014 / Draft Guidance , Enforcement Guidance , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Public Comment

FDA's Proposed Oversight of Laboratory Developed Tests - Industry Impact

The U.S. Food and Drug Administration (FDA) recently announced that the Agency is lifting its enforcement discretion over high-risk laboratory developed tests (LDTs). The FDA’s “LDT Guidance” was reviewed in detail in my...more

9/24/2014 / Food and Drug Administration (FDA) , Guidance Update , Healthcare , Laboratory Developed Tests , Non-Enforcement

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

8/4/2014 / Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratories , Diagnostic Tests , Draft Guidance , Enforcement , Food and Drug Administration (FDA) , Healthcare , Laboratory Developed Tests , National Institute of Health (NIH) , Physicians

FDA's Plan to Regulate LDTs

In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more

6/17/2013 / DNA , Enforcement , Food and Drug Administration (FDA) , Laboratory Developed Tests , Regulation

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

2/25/2013 / Centers for Medicare & Medicaid Services (CMS) , Diagnostic Tests , Food and Drug Administration (FDA) , Labeling , Laboratory Developed Tests , Marketing , Personalized Medicine , Pharmaceutical Industry

Antoinette Konski

Foley & Lardner LLP

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