FDA Issues Final Rule Amending Medical Device Classification Regulations

April 16, 2021 — The U.S. Food and Drug Administration (FDA) issued the final rule: Medical Device Classification Regulations to Conform to Medical Software Provisions in 21st Century Cures Act. The final rule amends eight classification regulations so the regulations conform to the medical software provisions of the Cures Act and reflect the FDA’s current statutory authority, and amends the “identification” description of eight classification regulations so the regulations no longer include software functions that the Cures Act excluded from the device definition. You can read the final rule here.