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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
- 21 U.S. Code § 351 - Adulterated drugs and devices . U.S. Code ; ... packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it …
New Jersey Medical Device Manufacturer Admits Selling …
- https://www.justice.gov/opa/pr/new-jersey-medical-device-manufacturer-admits-selling-contaminated-ultrasound-gel-court
- The devices at issue are gels that doctors and hospitals use to take ultrasound scans, sonograms, EKGs and similar procedures. Pharmaceutical Innovations Inc. …
Overview of Regulatory Requirements: Medical Devices
- https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
- Adulteration could be placing a device on the market that requires a marketing application such as a 510(k), but the firm failed to get that 510(k) clearance. ... Now let's look at …
New Jersey Medical Device Manufacturer Admits Selling …
- https://www.justice.gov/usao-nj/pr/new-jersey-medical-device-manufacturer-admits-selling-contaminated-ultrasound-gel
- “Today’s plea agreement and civil settlement require Pharmaceutical Innovations to accept responsibility for the contamination and take the necessary steps …
FDA 483 Observations and Warning Letter Trends - FDAnews
- https://www.fdanews.com/ext/resources/files/Conference2/FIS19Presentations/Damron-FDA-483-and-Warning-Letter-Trends.pdf
- contamination with a positive test result, yet distributed the lots that tested positive after a “clean” re- ... • CGMP/QSR/Medical Devices/Adulterated –Warning Letter to Oxford …
Contamination Control in Medical Devices, …
- https://www.exponent.com/services/practices/engineering/biomedical-engineering-sciences/capabilities/contamination-control-in-medical-devices-pharmac__
- Their presence leads to the contamination of process equipment, raw materials, and in some cases, product adulteration leading to recalls. Effective control of bioburden in …
List of medicine contamination incidents - Wikipedia
- https://en.wikipedia.org/wiki/List_of_medicine_contamination_incidents
- In medicinal chemistry, the term "contamination" is used to describe harmful intrusions, such as the presence of toxins or pathogens in pharmaceutical drugs. [1] The following …
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, …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110&showFR=1
- (a) The criteria and definitions in this part shall apply in determining whether a food is adulterated (1) within the meaning of section 402(a)(3) of the act in that the …
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