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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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