Health Law Advisor

JULY 5, 2022

To help medical device manufacturers focus on the types of quality problems that might force them to conduct a recall, we have used the FDA recall database to identify the most common root causes sorted by the clinical area for the medical device. This heat map shows everything from one recall to 150 in each category. Background.

FDA 52

FDA 52

Drug & Device Law

APRIL 18, 2022

The Wisconsin guest post let us know about a pending decision that – we all hoped – would take that state out of the “no state appellate precedent” category altogether: Wisconsin has recently made it to the red zone, and may soon cross the goal line, with the Wisconsin Court of Appeals’ forthcoming decision in Rennick v. Teleflex Med.

FDA 59

FDA 59

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72