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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 …
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 …
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