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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
Labeling Requirements - Misbranding | FDA
- https://www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-misbranding
- Section 502 of the Federal Food, Drug and Cosmetic Act (FFDCA) contains provisions on misbranding including some that relate to false or misleading labeling. A device’s labeling …
Overview of Regulatory Requirements: Medical Devices
- https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
- The law is very clear in that no medical device shall be adulterated or misbranded. Those are the two violations that the Office of Compliance will issue a letter for to medical …
CFR - Code of Federal Regulations Title 21
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=800.55
- (a) General. This section sets forth the procedures for detention of medical devices intended for human use believed to be adulterated or misbranded. …
Misbranded & Adulterated Medical Devices - FDA …
- https://blog.clevercompliance.io/medical-product-compliance/misbranded-adulterated-medical-devices/
- A misbranded product is any device that contains false or misleading labelling. However, as with adulteration, the FDCA has an expanded definition which …
Three Individuals and One Company Indicted for …
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/three-individuals-and-one-company-indicted-introducing-adulterated-and-misbranded-devices-interstate
- The FDCA prohibits, among other things, the knowing introduction and delivery in interstate commerce of a device that is misbranded or adulterated. The …
RightEye receives FDA warning that its product is a medical device
- https://www.massdevice.com/righteye-fda-warning-medical-device/
- 2 days ago · An FDA inspection claims that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device. The agency wrote in a letter, dated …
Doctor Pleads Guilty to Using Misbranded and …
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/doctor-pleads-guilty-using-misbranded-and-adulterated-products-sold-botox-and-juvederm
- Her medical practice, Lindsay Clark, M.D., Medical Corporation, also pleaded guilty to one felony count of receiving and delivering misbranded drugs and misbranded and …
Doctor Pleads Guilty to Using Misbranded and …
- https://www.justice.gov/opa/pr/doctor-pleads-guilty-using-misbranded-and-adulterated-products-sold-botox-and-juvederm
- Dr. Lindsay Clark, 45, pleaded guilty to one misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by receiving and delivering …
Dental practice owners charged with fraud and RICO …
- https://www.irs.gov/compliance/criminal-investigation/dental-practice-owners-charged-with-fraud-and-rico-conspiracy
- Conspiracy to place adulterated and misbranded dental devices in commerce. Conspiracy To Distribute an Adulterated and Misbranded Medical Device …
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