US Regulatory Roundup, April 2021: Medical Software, FDA Remote Reg Assessments, Medtronic Recalls, And More
• By Shawn M. Schmitt
An FDA rule that says the agency will no longer regulate eight different types of medical software, an explainer of the FDA’s Remote Regulatory Assessments, high-risk class I recalls for medtech giant Medtronic, and more topped our list of most-read Medtech Insight articles in April.
If you’re the maker of any of eight different types of medical software, then you can breathe easy: A final rule from the US Food and Drug Administration that went into effect in mid-April says the agency won’t regulate the programs anymore because they’re not devices in the eyes of the FDA.
