USA – FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do...
Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). The...
USA – FDA proposes updates to Breakthrough Devices Program guidance
The US Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance, expanding its...
USA – FDA issues road map to medical device regulatory guidance topics list for...
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 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...
