Fda Warning Letters Medical Device Hazards

Warning Letters | FDA - U.S. Food and Drug Administration

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

Main FDA Warning Letter Page. Main FDA Warning Letter Page ... Market Withdrawals and Safety Alerts; Press Announcements; ... CGMP/QSR/Medical Devices/Adulterated : 02/07/2023: 12/27/2022 ...

Letters to Industry | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/industry-medical-devices/letters-industry

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. ... FDA Issues Two Warning Letters to Leading …

Medical Device Safety | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety. The FDA monitors reports of adverse events and other …

2022 Safety Communications | FDA

https://www.fda.gov/medical-devices/safety-communications/2022-safety-communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical …

Safety Communications | FDA

https://www.fda.gov/medical-devices/medical-device-safety/safety-communications

Listing of Medical Device Safety Communications to describe FDA’s analysis of a current issue and provide specific regulatory approaches and clinical …

Letters to Health Care Providers | FDA

https://www.fda.gov/medical-devices/medical-device-safety/letters-health-care-providers

The FDA posts the letters it sends to health care providers about safety concerns with medical devices used in health care facilities.

FDA Issues Two Warning Letters to Leading …

https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-issues-two-warning-letters-leading-manufacturer-endoscopes

January 10, 2023. The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. The FDA’s Center for …

Warning Letters | FDA - U.S. Food and Drug Administration

https://cacmap.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of …

FDA warning letter cites product safety issues in Medtronic …

https://www.medtechdive.com/news/fda-warning-letter-medtronic-diabetes-group/616665/

The FDA flagged several product safety problems in a December warning letter to Medtronic's diabetes group, citing the medical device maker for not …