News & Analysis as of

Clinical Laboratory Testing Medical Devices

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Knobbe Martens

FDA Issues Warning about Fraudulent and Unreliable Laboratory Data

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The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing...more

Hogan Lovells

FDA webinar on speedy LDT rule finalization leaves key questions unanswered

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) signaled that it intends to finalize its laboratory developed test (LDT) proposed rule by April 2024. The new rule (if finalized as drafted) is intended to clarify the agency’s...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Issues Long-Awaited Proposed Rule To Regulate Laboratory-Developed Tests

On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more

Foley Hoag LLP

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

Foley Hoag LLP on

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

Epstein Becker & Green

Full Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown

Epstein Becker & Green on

In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

Jones Day

Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

Jones Day on

Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Patrick Malone & Associates P.C. | DC Injury...

Better Healthcare Newsletter from Patrick Malone - May 2021

IN THIS ISSUE Home medical tests and health monitors are trendy now. How useful are they? As the saying goes: Let the buyer beware - Shaking up hidebound medicine could be a plus. But will key safeguards also stay?...more

Vinson & Elkins LLP

Data Corruption: DOJ Targets Fraud In Medical Research Trial In The Era Of COVID-19

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In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more

Morgan Lewis

How a Biden Administration Will Affect FDA’s Regulation of Medical Devices

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Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more

Hogan Lovells

FDA finalizes guidance on non-clinical assessment of medical devices containing nitinol

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The U.S. Food and Drug Administration (FDA) has finalized their guidance related to medical devices that contain nitinol, the draft of which was published on April 19, 2019. The guidance recommends that companies clarify the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement Spotlight: US Prosecutors Continue To Target Medical Technology Companies

Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more

Seyfarth Shaw LLP

FDA Authorizes Synthetic Nasal Swab to Increase COVID-19 Testing

Seyfarth Shaw LLP on

Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more

K&L Gates LLP

COVID-19: K&L Gates Triage: FDA Facilitates Diagnostic Testing and Heightens Public Safety Efforts Amid Outbreak

K&L Gates LLP on

In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak. In...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

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Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Hogan Lovells

FDA finalizes guidances for NGS-based tests

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On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests. Unlike most IVDs that typically detect...more

Knobbe Martens

FDA Provides Guidance on 3D-Printed Medical Device Products

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The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more

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