In Westlaw Today, Joshua Oyster and Austin Laroche Examine FDA’s New Medical Device Inspection Approach

In a Westlaw Today article, life sciences regulatory & compliance partner Joshua Oyster and associate Austin Laroche examined the Food and Drug Administration's new inspection approach for medical device manufacturers under the Quality Management System Regulation and discuss key changes from prior inspection methods.

The authors note that medical device companies will likely also need to update their quality-related documents to reflect the heightened focus on risk management and conduct revised trainings to ensure that personnel are appropriately prepared for future FDA inspections. In particular, personnel should understand the new focus and scope of FDA inspections as well as the additional quality-related documents that investigators may request.