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Healthcare › Food and Drug Administration (FDA) › CLIA

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

Gardner Law on

In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

Foley & Lardner LLP

FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul

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After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more

McDermott Will & Schulte

In Case You Missed It: Highlights | When Digital and Life Sciences Intersect

McDermott Will & Schulte on

In this session, panelists discussed common pitfalls that life sciences companies face as they explore ways to incorporate digital-health strategies into product and service offerings, as well as approaches for successful...more

Mintz - Health Care Viewpoints

California Health Care Legislation Signed Into Law By Governor Newsom

Mintz - Health Care Viewpoints on

October 10th was the last day for Governor Newsom to sign or veto laws that were passed by the legislature this year. 2021 was a busy year for California legislators, who put forth hundreds of health-related bills in the wake...more

Polsinelli

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

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

Mintz

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

Mintz 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

Foley & Lardner LLP

Navigating the Diagnostic Commercialization Process

Foley & Lardner LLP on

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

Latham & Watkins LLP

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

Latham & Watkins LLP on

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

Foley & Lardner LLP

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

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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

Foley & Lardner LLP

Regulating Point of Care Diagnostics

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Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...more

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