Misbranded Medical Devices

Labeling Requirements - Misbranding | FDA

https://www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-misbranding

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 ...

General Controls for Medical Devices | FDA

https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices

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 also …

2020 Warning Letters - Health Fraud | FDA

https://www.fda.gov/consumers/health-fraud-scams/2020-warning-letters-health-fraud

New Drug/Misbranded: 12/22/2020: ... Durazo Medical Biomagnetism: Center for Devices and Radiological Health: Adulterated and Misbranded Products …

Pentax Medical Company Agrees to Pay $43 Million to …

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/pentax-medical-company-agrees-pay-43-million-resolve-criminal-investigation-concerning-misbranded

Pentax was charged in a criminal complaint filed today in Newark federal court with distributing misbranded medical devices in interstate commerce in violation of the …

21 U.S. Code § 352 - Misbranded drugs and devices

https://www.law.cornell.edu/uscode/text/21/352

with respect to devices described under paragraph (1) of such section, 12 months after the date of enactment of the Medical Device User Fee Stabilization Act of 2005 ... Guidance; …

Pentax Medical Company Agrees to Pay $43 Million to …

https://www.justice.gov/opa/pr/pentax-medical-company-agrees-pay-43-million-resolve-criminal-investigation-concerning

Pentax was charged in a criminal complaint filed today in Newark federal court with distributing misbranded medical devices in interstate commerce in violation of the …

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 …

CFR - Code of Federal Regulations Title 21

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

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 800.55 Administrative detention. (a) General. This …

Dental Practice Owners Charged with Fraud and RICO …

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/dental-practice-owners-charged-fraud-and-rico-conspiracy

Conspiracy To Distribute an Adulterated and Misbranded Medical Device in Interstate Commerce: (5 years) Sunil Philip Conspiracy to commit racketeering, money laundering …