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Clinical Laboratories Medical Devices Coronavirus/COVID-19

Venable LLP

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

Venable LLP on

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | December 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between November 21 and December 31, 2022, including recent enforcement activity and a summary of the Office of Inspector...more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #3

Alston & Bird on

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

Akin Gump Strauss Hauer & Feld LLP

Diagnostics Reform Heats Back Up with Introduction of the Verifying Accurate Leading-edge IVCT Development Act of 2021

In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more

Mintz - Health Care Viewpoints

The VALID Act, Aiming to Reform the Regulation of Diagnostic Products, Is Finally Introduced in Congress

Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the...more

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