FDA classifies medial knee implanted shock absorbers as Class II devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will hold a public meeting to review Capricor's biologics license application for Deramiocel, a cell therapy product, with public comment accepted via docket submission.
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After healthcare come the capital-heavy sectors: trade, transportation, energy, and finance. If you operate in one of them, the volume of change is relentless.
Federal agencies seek public comment on pilot protocols for recreation monitoring under Section 133 of the EXPLORE Act at ten or more land management units per agency to track low-use and dispersed recreation activities.
SEC proposes to extend the information collection requirements under Rule 15g-9, which governs penny stock sales disclosures and broker-dealer compliance obligations for small-cap equity markets.
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FAA supersedes prior airworthiness directives for Airbus Helicopters Models AS332C, AS332C1, AS332L, and AS332L1 by requiring modification of cabin lateral sliding plug door release or jettison systems to terminate repetitive inspections.
FAA airworthiness directive mandates repetitive inspections and corrective actions for fastener holes in Airbus A321-251NX through A321-272NX center fuselage frame foot joints due to manufacturing process deviations.
USDA seeks public comment on renewal of OMB approval for Optional Form OF-2211, which collects data on Build America, Buy America waiver requests from federal contractors and grant recipients.
FAA airworthiness directive requires Airbus Helicopters AS350 series operators to inspect cargo hook gaps and replace affected units or prohibits their installation to address safety non-conformities.
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