Fda Warning Letters 2012 Medical Devices

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

Learn about the types of warning letters on FDA's website. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA …

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

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

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 …

Warning Letters Highlight Differences Between …

https://www.fda.gov/cosmetics/warning-letters-related-cosmetics/warning-letters-highlight-differences-between-cosmetics-and-medical-devices

FDA warning letters issued to manufacturers and/or distributors of devices marketed for regrowing hair, weight reduction, spider vein removal, and dermabrasion, as …

Letters to Health Care Providers | FDA

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

Medical Device Safety Letters to Health Care Providers Letters to Health Care Providers The most recent letters to health care providers are listed by year in the left navigation. …

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

FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes Violations include failure to adhere to medical device reporting requirements and quality …

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

Warning Letters Learn about the types of warning letters on FDA's website. Matters described in FDA warning letters may have been subject to subsequent interaction …

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

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

FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical …

Olympus Medical Systems Corporation - 649726

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/olympus-medical-systems-corporation-649726-12122022

Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), these products are devices because they are intended for use in the …

RightEye receives FDA warning that its product is a medical device

https://www.massdevice.com/righteye-fda-warning-medical-device/

February 15, 2023 By Sean Whooley An FDA inspection claims that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device. …