FDA Law

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. By Steven J. Gonzalez & Lisa M. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law

DECEMBER 12, 2023

We know what you must be thinking: “With all this crystal formation, why don’t they call them Glitter boxes?” (Apologies to our readers—word play is FDA Law Blog’s catnip.) RSS is a measurement used to estimate the potential for crystal formation and bladder stone (urolith) growth, a common affliction in cats.

Utilities 59

Utilities Manufacturing Provider Individual 59

FDA Law

APRIL 19, 2021

We have blogged recently about several FDA setbacks in court ( here , for example). Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

Manufacturing 40

Manufacturing Government Medical IT 40

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198).

Manufacturing 64

Manufacturing Physicals Provider Electronics 64