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    • LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—N.D. Ill.: Consumer class action over lemon content in Polar Corp.’s seltzer fizzles
    • ADMINISTRATION OF FDC ACT—NOTICES: Determination of regulatory review period for purposes of patent extension of biologic ESPEROCT
    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—DAB DECISIONS: Avoidable human error, not good cause, resulted in untimely hearing request
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    • FALSE CLAIMS ACT—SETTLEMENT AGREEMENTS: Neurosurgeon, medical device distributor to pay $825K+ to settle FCA, AKS allegations
    • GENERAL HEALTH CARE NEWS—NOTICES: ‘Low-Income Levels’ used for various health professions, nursing programs authorized in the Public Health Service Act
    • LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—N.D. Ill.: Consumer’s deceptive labeling claims about Brach’s caramel candy failed to stick to labeling details
    • MEDICAL DEVICES—FINAL RULES: Technical amendments to medical device regulations
    • PHARMACEUTICAL NEWS: Experts discuss 340B trends and litigation during AHLA session
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    Health Law Daily Wrap Up, MEDICAL DEVICES—FINAL RULES: Technical amendments to medical device regulations, (Mar 23, 2023)

    By WK Editorial Staff

    The final rule does not impose any new regulatory requirements on affected parties.

    The FDA amended certain medical device regulations to update mailing address and docket number and conform the regulatory provisions to the Federal Food, Drug, and Cos ...

    By WK Editorial Staff

    The final rule does not impose any new regulatory requirements on affected parties.

    The FDA amended certain medical device regulations to update mailing address and docket number and conform the regulatory provisions to the Federal Food, Drug, and Cosmetics Act (FDC Act). As a part of the technical amendment, the FDA Center for Devices and Radiological Health (CDRH) is making changes to 21 CFR parts 10, 803, 812, and 822 to ensure accuracy and clarity in the Agency’s medical device regulations. The action is editorial in nature to correct errors (Final Rule, 88 FR 16878, March 21, 2023).

    Dates. The rule is effective March 21, 2023.

    FederalRegisterIssuances: FinalRules FDCActNews MDeviceNews

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