News & Analysis as of

Diagnostic Tests

McAfee & Taft

New ADA regulations issued on the accessibility of medical diagnostic equipment used by public entities

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On August 9, 2024, the U.S. Department of Justice published a final rule implementing new ADA requirements for accessible medical diagnostic equipment (MDE) used in hospitals, emergency departments, physicians’ offices,...more

Polsinelli

Challenges to LDT Final Rule Continue as Rule Goes into Effect

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As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more

Davis Wright Tremaine LLP

Stay ADvised: 2024, Issue 13

Initial Attempt at Pinning Presence of PFAS in Coca-Cola Juice Drink as False Advertising Fizzes Out - The U.S. District Court for the Southern District of New York dismissed a plaintiff's initial complaint against...more

Arnall Golden Gregory LLP

The Boys Are Back in Town: FDA’s Draft Guidance for Compliance With the Phase-Out of LDT Enforcement Discretion

Thin Lizzy famously declared in their 1976 hit, “The Boys are Back in Town.” The same is true almost 50 years later, as the U.S. Food and Drug Administration has announced its plan to phase out its general enforcement...more

Nelson Hardiman, LLP

The Limits of AI in Healthcare: Exploring Ethical and Practical Challenges

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Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more

Stikeman Elliott LLP

Ontario Issues Call for Applications for Community Surgical and Diagnostic Centers

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Ontario has (finally!) made the call to community surgical and diagnostic centers for applications for new licences under the Integrated Community Health Services Centres Act, 2023 (the Act) to provide MRI and CT services. ...more

Venable LLP

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

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The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more

Venable LLP

Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"?

Venable LLP on

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286) that will, over the next four years, radically alter the landscape for laboratory developed tests (LDTs). This action...more

Manatt, Phelps & Phillips, LLP

FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests

On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the...more

Hendershot Cowart P.C.

Do Cosmetic Injections Involve The Practice Of Medicine?

Cosmetic injections, such as Botox and dermal fillers, and weight-loss injections, such as Wegovy® and Ozempic®, are popular offerings at med spas, weight-loss clinics, and dermatology practices. But are they considered the...more

J.S. Held

Accuracy of 2016-2022 EDRs in IIHS Crash Tests

J.S. Held on

Abstract - Event data recorders (EDRs) were harvested and imaged after Insurance Institute for Highway Safety (IIHS) 56 km/hr frontal and 64.4 km/hr frontal offset crashes of 15 different brands of 2016-2022 vehicles. The...more

BakerHostetler

FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests

BakerHostetler on

The U.S. Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed tests (LDTs). LDTs are in vitro diagnostic products (IVDs) that...more

Holland & Knight LLP

FDA Announces Final Regulation Governing Laboratory Developed Tests

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The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices....more

Goodwin

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

Goodwin on

On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). This final ruling amends the FDA’s regulations to make explicit that in vitro diagnostic products...more

MoFo Life Sciences

Non-Lab Diagnostics: FDA Regulatory Considerations

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The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more

MoFo Life Sciences

At-Home Diagnostics Articles: Non-Lab Diagnostics: Supply, Manufacturing, And Distribution Agreements

MoFo Life Sciences on

The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more

Manatt, Phelps & Phillips, LLP

Congress Revisits Longstanding Debate Over FDA Regulation of Lab-Developed Tests

On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” In the wake of...more

MoFo Life Sciences

Non-Lab Diagnostics: Consumer And User Agreements

MoFo Life Sciences on

The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more

Morgan Lewis

A First Step? Reclassification of High-Risk LDTs Assists FDA with Oversight of LDTs

Morgan Lewis on

The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Justice Department Proposes ADA Regulations Impacting Healthcare Industry

On January 12, 2024, the U.S. Department of Justice (DOJ) published a notice of proposed rulemaking (NPRM) under Title II of the Americans with Disabilities Act (ADA) that would require accessible medical diagnostic equipment...more

Akin Gump Strauss Hauer & Feld LLP

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

Goodwin

FDA Targets April 2024 for Laboratory Developed Test (LDT) Final Rule

Goodwin on

On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding...more

Napoli Shkolnik

Diagnostic Errors Claim Nearly 800,000 American Lives Per Year, Study Finds

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A new study shows that approximately 371,000 people die and 424,000 sustain permanent disabilities due to diagnostic error, including brain damage, blindness, loss of limbs or organs or metastasized cancer....more

McDonnell Boehnen Hulbert & Berghoff LLP

International Trade Commission Issues Report of COVID-19 IP Waiver

It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more

Foley & Lardner LLP

USPTO Report On COVID-19 Diagnostic Patent Filings

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The U.S. Patent and Trademark Office (USPTO) released a report on innovations in COVID-19-related diagnostics as a case study of how innovation and intellectual property operate during times of crisis. The study utilized...more

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