FDA Law

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection. Javitt & Jeffrey N.

Telehealth 72

Telehealth Patients Manufacturing Transportation 72

FDA Law

JUNE 22, 2023

By McKenzie E. Cato & Jeffrey N. Gibbs & Allyson B. Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. FDA, in turn, filed its own statement “to address misinformation” (see FDA’s statement here ). lay users). seeking treatment).

Manufacturing 59

Manufacturing Clinic IT Transportation 59

FDA Law

AUGUST 3, 2021

Although the bipartisan bill largely deals with the nation’s transportation infrastructure, Section 90006 delays the so-called “rebate rule,” a Trump-era rule finalized by the Office of the Inspector General (OIG) of the U.S. By Faraz Siddiqui — On Monday August 2, 2021, the Senate took up for review H.R.

Manufacturing 52

Manufacturing Transportation Government Management 52