Definition Of Adulterated Medical Device

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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 … 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 …

CFR - Code of Federal Regulations Title 21

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=800.55

(1) The detention order shall be issued in writing, in the form of a detention notice, signed by the authorized FDA representative who has reason to believe that the …

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 …

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 …

Overview of Regulatory Requirements: Medical Devices

https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

It basically says a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man”. Some …

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 …

adulterated medical device Definition | Law Insider

https://www.lawinsider.com/dictionary/adulterated-medical-device

adulterated medical device means a medical device which consists in whole or in part of an impure or decomposed substance; or if the medical device has been manufactured, …

Adulterated Definition & Meaning - Merriam-Webster

https://www.merriam-webster.com/dictionary/adulterated

adul· ter· at· ed ə-ˈdəl-tə-ˌrā-təd Synonyms of adulterated : weakened or lessened in purity by the addition of a foreign or inferior substance or element adulterated food Synonyms …

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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