FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The statute achieves this through disclosure of information by the software manufacturer about the “basis for” the recommendations made by the software.

Clinic 52

Clinic Medical Provider Patients 52

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. There have been a few severe cases and one individual died with H5N1 infection. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98