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.
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.
The Agency for Healthcare Research and Quality seeks OMB approval to extend the AHRQ Research Reporting System information collection with reduced annual burden and expanded scope to include grants, contracts, and challenge competitions.
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.
Center for Scientific Review amended notice of meeting for the National Institutes of Health scientific review group; meeting details and date available in Federal Register notice.
Final rule eliminates obsolete regulations governing repatriation and care of US nationals returned from foreign countries, streamlining bureaucratic requirements for human services and emergency response programs.
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Center for Scientific Review will hold closed meetings to review research grant applications and provide advice on scientific matters to the National Institutes of Health.
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.
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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.
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