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.
Treasury proposes Privacy Act exemption for a new system tracking federal program waste, fraud, and abuse tips to protect investigatory records from disclosure requirements.
Treasury establishes a new system of records to receive and triage public tips about suspected fraud, waste, and abuse in Federal programs for referral to appropriate agencies and inspectors general.
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.
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Treasury Department seeks public comment on the Fraud.gov tip intake system's information collection burden under the Paperwork Reduction Act of 1995.
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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