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The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 25-09 on August 12,...
Reed Smith LLP
The Department of Health and Human Services, Office of Inspector General (OIG) recently released an advisory opinion (Advisory Opinion...
In an advisory opinion released June 30th, the U.S. Department of Health and Human Services Office of Inspector General (OIG) confirmed...
The Department of Health and Human Services Office of Inspector General (OIG) recently released Advisory Opinion 25-04, concluding that a...
On May 14, 2024, FDA hosted a webinar to provide an overview of its final rule “Medical Devices; Laboratory Developed Tests” as well as...
On October 31, FDA will be offering a webinar on its proposed rule ”Medical Devices; Laboratory Developed Tests.” This webinar comes...
On September 15, 2023, FDA published an update to the guidance document – “Breakthrough Devices Program, Guidance for Industry and Food...
On February 28, 2023, six of the seven Medicare Administrative Contractors (MACs), who administer Medicare reimbursement on behalf of the...
[Note, this is Part 2 in an ongoing series of posts exploring substantive aspects of the Consolidated Appropriations Act, 2023 (P.L....
On September 27, 2022, FDA announced the publication of a final guidance document entitled Clinical Decision Support Software, Guidance...
Last month’s leaked U.S. Supreme Court draft majority opinion from Justice Alito in Dobbs v. Jackson Women’s Health Organization that...
In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical...
On March 18, 2022, the Advanced Medical Technology Association (AdvaMed) – the world’s largest trade organization representing medical...
On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device...
On August 2, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule amending existing regulations (21 C.F.R. §...
On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing,...