US Regulatory Roundup, April 2021: Medical Software, FDA Remote Reg Assessments, Medtronic Recalls, And More

04 May 2021

• 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.

Our reporting on the new rule was of most interest to Medtech Insight readers in April.