Here are the top medtech regulatory stories on MassDevice and Medical Design & Outsourcing in 2022:
10. Philips’ respiratory devices recall has even more problems
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.
9. FDA proposes major changes to medical device quality regulation
The goal is for U.S. medical device quality regulation to better align with regulations worldwide.
8. Has the CE mark lost its appeal for novel medical device developers?
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.
7. Olympus launches power morcellator with FDA-advised changes
In 2020, the FDA issued final guidance on power morcellators after the devices faced questions about potentially spreading cancer.
6. FDA can’t explain drop in device recalls, but experts point to COVID disruptions
The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while medtech regulatory experts point to fewer inspections and fewer procedures.
5. Neuralink reportedly faces probe over animal testing
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.
4. Hearing aids start selling over-the-counter in the US
In August, the FDA issued a final ruling to create a new category of over-the-counter hearing aids.
3. FDA reports sterilization challenge progress as EPA takes aim at EtO emissions
The FDA highlighted work with the medical device industry to reduce EtO usage and develop new sterilization methods.
2. New medical device user fees agreement passes Congress
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.
1. European Commission proposes EU MDR deadline delay until 2028
The European Union’s Health Commissioner proposed pushing back the deadline for its new medical device regulation (MDR) law.
