Too Soon To Say If US FDA Device Reforms Are Working, Says Independent Report
This article was originally published in SRA
The US Food and Drug Administration has adopted all of the recommendations that consulting firm Booz Allen Hamilton has made in the past two years to improve its medical device review process, but it is still too early to say if the changes have improved overall performance.
You may also be interested in...
FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.
The EU Batteries Regulation is yet another legal instrument medical device manufacturers must address over the coming years alongside the core Medical Device and IVD Regulations.
Worryingly, however, British consumers are also increasingly turning to social media for health information, and rejecting it if it conflicts with what they believe, or if it is not based on personal experience.