USA – FDA proposes breakthrough status for devices that address health disparities
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in...
USA – FDA issues roadmap to medical device regulatory guidance topics list for 2023
The US Food and Drug Administration has released a list of guidance documents it plans to issue over its 2023 fiscal year. FDA’s Center...
USA – FDA launches TAP Pilot to speed access to safe and innovative medical...
The US Food and Drug Administration announced that it has launched a pilot program designed to foster earlier conversations in the medical device product...
USA – FDA device center guidance priority lists targets COVID, digital health
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Much of the...
USA – FDA finalizes which clinical decision software functions it regulates
The US Food and Drug Administration (FDA) announced that it has finalized guidance on which clinical decision software (CDS) functions it regulates as a...
USA – FDA will begin accepting breakthrough devices for TAP pilot in 2023
The US Food and Drug Administration (FDA) will start accepting products into its total product lifecycle advisory program (TAP) pilot starting in January. The...
USA – US FDA sets some steep increases for 2023 medical device user fees
The US Food and Drug Administration announced that it has set medical device user fees for fiscal year 2023. Medical device manufacturers and importers seeking...
USA – FDA finalizes guidances on device post-approval studies, postmarket surveillance
The US Food and Drug Administration (FDA) on 7 October released two final guidances to assist manufacturers of moderate- to high-risk medical devices to...
USA – Legal expert: FDA’s CDS software guidance is a ‘disaster’ for industry
The US Food and Drug Administration’s (FDA) final guidance on clinical decision support (CDS) software goes against the statutory language laid out in the 21st Century...
USA – FDA updates guidances to reflect new MDUFA goals
The US Food and Drug Administration has updated three guidances to reflect revised timelines for responding to premarket approval (PMA), 510(k) and de novo applications under...
