FDA classifies radiological machine learning-based quantitative imaging software with predetermined change control plans as Class II medical devices, subject to special controls to ensure safety and effectiveness.
The FDA issues a final 5-year debarment order against Andrew Jonathan Morgan, prohibiting him from importing or offering for import any drug into the United States based on a federal felony conviction related to drug importation.
The Federal Aviation Administration proposes to expand Class E airspace northwest of Bridgewater Air Park in Staunton, VA to accommodate new instrument approach procedures and update airport geographic coordinates.
FDA classifies ingestible gastrointestinal blood detection capsules as class II devices, establishing special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
FAA supersedes Airworthiness Directive 2022-11-08 for Airbus Helicopters Models AS350 and EC130 series by requiring revised airworthiness limitations in maintenance manuals and inspection programs to address unsafe conditions.
FAA airworthiness directive requires operators of Airbus Model AS350B2, AS350B3, EC130B4, and EC130T2 helicopters to revise maintenance manuals and inspection programs to comply with new safety limitations.
FDA corrects withdrawal of approval for 11 abbreviated new drug applications; Masuu Global Solutions LLC's propranolol and lidocaine ANDAs remain approved as of March 23, 2026.
Amor Fati Industries Corp petitioned the FAA for exemption from specified Federal Aviation Regulations; this notice invites public comment on the exemption request.
FAA supersedes Airworthiness Directive 2022-19-13 to impose more restrictive airworthiness limitations on Airbus Helicopters Models AS355E through AS355NP by requiring revision of maintenance manuals and inspection programs.
FAA airworthiness directive superseding 2023-01-04 requires inspections and corrective actions on Airbus Helicopters Models AS350 and AS355 series tail rotor head components while eliminating repetitive black paint marking checks.
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