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General Controls for Medical Devices | FDA

    https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices
    Medical devices are subject to the adulteration provisions of the FD&C Act under Section 501. The first two provisions of Section 501 define adulteration for most cases. A device is held to be adulterated if it includes any filthy, putrid, or decomposed substance, or if it is prepared, packed, or held under unsan… See more

21 U.S. Code § 351 - Adulterated drugs and devices

    https://www.law.cornell.edu/uscode/text/21/351
    A drug or device shall be deemed to be adulterated—. (a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture. (1) If it consists in whole or in part of any …

Misbranded & Adulterated Medical Devices - FDA …

    https://blog.clevercompliance.io/medical-product-compliance/misbranded-adulterated-medical-devices/
    An adulterated medical device is any product that has been corrupted or debased by incorporating an impure or spurious substance. The FDCA has …

Raleigh Physician Found Guilty of Using Adulterated and …

    https://www.justice.gov/usao-ednc/pr/raleigh-physician-found-guilty-using-adulterated-and-insanitary-medical-equipment
    Raleigh Physician Found Guilty of Using Adulterated and Insanitary Medical Equipment on Patients During Nasal Surgeries. Share. U.S. Attorney's Office, Eastern …

Adulterated | definition of Adulterated by Medical dictionary

    https://medical-dictionary.thefreedictionary.com/Adulterated
    Adulterated. adjective Referring to a drug or device which: contains decomposed or putrid material; has been produced, prepared, packed or held under unsanitary conditions, …

Adulteration | definition of adulteration by Medical dictionary

    https://medical-dictionary.thefreedictionary.com/adulteration
    adulteration. Pharmacology The substitution of one material or substance for another, such that a manufactured product is incorrectly labeled and/or dosage information …

Raleigh Physician Found Guilty Of Using Adulterated …

    https://oig.hhs.gov/fraud/enforcement/raleigh-physician-found-guilty-of-using-adulterated-and-insanitary-medical-equipment-on-patients-during-nasal-surgeries/
    – After a three-week federal jury trial, and 5 hours of jury deliberation, Anita Louise Jackson, 59, was found guilty on charges of adulterating medical devices for use …

Adulterated Definition & Meaning - Merriam-Webster

    https://www.merriam-webster.com/dictionary/adulterated
    Dylan Tokar, WSJ, 2 Feb. 2023 And while most of those overdoses involved the illicit synthetic opioid fentanyl, experts say that an adulterated and contaminated drug …

adulterated medical device Definition | Law Insider

    https://www.lawinsider.com/dictionary/adulterated-medical-device
    adulterated medical device. definition. adulterated medical device means a medical device which consists in whole or in part of an impure or decomposed substance; or if the …

What does "adulterated" mean? - USDA

    https://ask.usda.gov/s/article/What-does-adulterated-mean
    The definition for adulterated is found in 9 CFR 301.2. Adulterated shall apply to any carcass, part thereof, meat or meat food product under one or more …



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