FDA guidance eases wearables oversight. But experts have questions about what’s next.

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
MD&M East

8 Sterilization FAQs Every Medical Device Manufacturer Must Know

As the medical device industry faces growing regulatory pressure and evolving sterilization challenges, ensuring biological safety and product sterility is more complex than ever. In this Q&A, Nicole ...
Health Affairs

Reforming The Medical Device Recall Process—A Call For Accountability

The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a ...