Here are the top medtech regulatory stories on MassDevice and Medical Design & Outsourcing in 2022:
It’s one of the most serious recalls that the medical device industry has ever seen, involving millions of devices. The situation became even worse in November when Philips announced some ventilators reworked as part of the recall had new problems.
The goal is for U.S. medical device quality regulation to better align with regulations worldwide.
Medtech companies are increasingly looking to the FDA instead of Europe’s CE mark when launching novel products, according to a report published by Boston Consulting Group and the UCLA Biodesign innovation hub.
In 2020, the FDA issued final guidance on power morcellators after the devices faced questions about potentially spreading cancer.
The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while medtech regulatory experts point to fewer inspections and fewer procedures.
Reuters reported that Elon Musk’s brain-computer interface venture Neuralink faces an animal welfare investigation by the U.S. Department of Agriculture Inspector General.
In August, the FDA issued a final ruling to create a new category of over-the-counter hearing aids.
The FDA highlighted work with the medical device industry to reduce EtO usage and develop new sterilization methods.
MDUFA V includes a new medtech regulatory mechanism where the FDA will be able to increase fees in later years if it meets goals related to timely review of submissions.
The European Union’s Health Commissioner proposed pushing back the deadline for its new medical device regulation (MDR) law.