JD Supra

FDA Finalizes ‘Instructions for Use’ Guidance on Patient Labeling for Drugs and Biologics

As companies begin planning for the upcoming year, attorneys who sit on promotional review committees should consider the significant guidance published by the U.S. Food and Drug Administration (“FDA” ...
JD Supra

European Commission adopts a Regulation on electronic instructions for use for MDR-covered devices

The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain medical devices subject to the Medical Devices ...
MD&M East

Abiomed Impella ‘Instruction for Use’ Recall Linked to 49 Deaths

After a 2023 marred by recalls and FDA wrath, Johnson & Johnson subsidiary Abiomed has once again issued a recall connected to its Impella blood pumps. Categorized as Class I, the most recent recall ...
Healio

FDA approves updated instructions of use for implanted neuromodulation device for HF

Please provide your email address to receive an email when new articles are posted on . The FDA approved revised instructions for use for a neuromodulation device for HF. The instructions now include ...