The FDA today issued a ruling that amends medical device classification regulations related to the 21st Century Cures Act. In an unpublished ruling (it will officially be published on Monday, April 19, 2021), the FDA stated that it took this action to ensure that its regulations conform to the medical software provisions in the Cures […]
21st Century Cures Act
FDA grants breakthrough device status to MediBeacon
MediBeacon (St. Louis) recently announced that it has won FDA breakthrough device designation for its Transdermal GFR Measurement System (TGFR). TGFR is one of several products granted breakthrough status, FDA’s expedited path outlined in the 21st Century Cures Act. The product measures glomerular filtration rates (GFRs) in patients with impaired or normal renal function. TGFR is considered […]
House to vote this week on 21st Century Cures Act
The U.S. House of Representatives is set to vote this week on the 21st Century Cures Act, which looks to speed up FDA approval of both new drugs and devices, as well as provide a boost in funding for medical research. Leaders of the House and Senate said late on Friday they worked out a […]
Report: FDA, medtech in bed on 21st Century Cures Act
The FDA and the medical device industry reportedly collaborated on drafting the 21st Century Cures Act before its passage in the U.S. House last summer, drawing criticism from consumer watchdogs and FDA experts. The 21st Century Cures Act, as approved on a 344-77 House vote in July, would speed new medical devices and drugs to the market […]
