Medtech Connect Episode 1: How Do We Regulate Software As A Medical Device?
Executive Summary
In the first episode of new podcast series Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews Foley and Lardner partner Kyle Faget about the complexities behind regulating software as a medical device (SaMD). Many companies are unsure if their software is even regulated by the FDA, let alone how to go about the clearance process. From managing cybersecurity risks to navigating digital health policy, Faget does it all, and she gives us insight into the regulatory landscape of SaMD in this month’s episode.
You may also be interested in...
What Can Tech Companies Teach Us About Clinical Trials?
Collaboration between tech companies and medical researchers may be the answer to modernizing clinical trials.
Four More Guidance Documents Released: Antimicrobial Devices, Closed-Loop Control Technology, De Novo Submissions, Devices For Graft Versus Host Diseases
The US FDA recently published four guidance documents, two final — one concerning antimicrobial susceptibility test system devices and another related to devices with physiologic closed-loop control technology. The agency’s two draft documents pertain to electronic submissions for de novo requests and graft-versus-host diseases.
Bill Covering Breakthrough Products ‘Step In The Wrong Direction,’ Researchers Say
Researchers from the Brigham and Women’s Hospital and Harvard Medical School argue that the Ensuring Patient Access to Critical Breakthrough Products Act is “a step in the wrong direction.”