Medical Device Government Investigations

Federal Indictments & Law Enforcement Actions in One …

https://www.justice.gov/opa/pr/federal-indictments-and-law-enforcement-actions-one-largest-health-care-fraud-schemes

One of the largest health care fraud schemes investigated by the FBI and the U.S. Department of Health and Human Services Office of the Inspector General (HHS …

Reporting Allegations of Regulatory Misconduct | FDA

https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Investigational Device Exemption (IDE) - 21CFR Part 812 An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in …

Medical Devices Harm Patients …

https://www.icij.org/investigations/implant-files/medical-devices-harm-patients-worldwide-as-governments-fail-on-safety/

The medical device lobby is a force in Washington. Over a 10-year period through 2017, the industry has spent more …

Medical Device Reporting | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/medical-device-reporting

The Medical Device Reporting (MDR) Regulation requires medical device manufacturers, device user facilities and importers to establish a system that ensures the prompt …

IDE Responsibilities | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-responsibilities

Under §812.5 an investigational device or its immediate package must bear a label with the following information: the name and place of business of the manufacturer, …

Medical Device Manufacturers | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/medical-device-manufacturers

Medical Device Manufacturers December 1997 4 GUIDE TO INSPECTIONS OF MEDICAL DEVICE MANUFACTURERS TABLE OF CONTENTS ATTACHMENTS Note: …

Eastern District of Pennsylvania | French Medical Device …

https://www.justice.gov/usao-edpa/pr/french-medical-device-manufacturer-pay-2-million-resolve-alleged-kickbacks-physicians

Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the U.S. Department of Health and Human …

Investigational Medical Devices - Hopkins Medicine

https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/devices.html

Medical devices include, among other things, surgical laser, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices …

Government Investigation Definition | Law Insider

https://www.lawinsider.com/dictionary/government-investigation

Government Investigation means a formal investigation instituted against an insured by any federal, state or local government agency or authority, the subject matter of which is …