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Medical Devices › Proposed Rules › Healthcare

McDermott Will & Schulte

CMS proposes RPM reimbursement updates, requests information on reimbursing for SaaS

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Over the past several years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to recognize and pay for non-face-to-face services that improve care management...more

Alston & Bird

Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Blake, Cassels & Graydon LLP on

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

Quarles & Brady LLP

FDA Publishes Final Rule on Regulation of Lab-Developed Tests

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On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

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The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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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...

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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

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Nelson Mullins Riley & Scarborough LLP on

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

Arnall Golden Gregory LLP

Roll With the Changes: FDA’s Proposed Amendments to Converge its Quality Management System Requirements With ISO Requirements

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In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more

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