Fda Warning Letters For 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 and the letter recipient...

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

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

2021 Letters to Health Care Providers | FDA

https://www.fda.gov/medical-devices/letters-health-care-providers/2021-letters-health-care-providers

04/09/2021. Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers. 04/01/2021. Potential for False Results with Roche Molecular …

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 …

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

The FDA’s Center for Devices and Radiological Health (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 …

FDA Issues Warning Letter to RightEye LLC

https://www.natlawreview.com/article/fda-issues-warning-letter-to-righteye-llc-misbranding-and-adulteration

In the Warning Letter, FDA wrote that, for the reasons discussed below, the device was: (i) misbranded due to promotion beyond its cleared indications for use, (ii) …

Wintech Medipro LLC - 640048 - 11/16/2022 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wintech-medipro-llc-640048-11162022

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 …

FDA Issues Warning Letter to RightEye, LLC For Misbranding …

https://www.lexology.com/library/detail.aspx?g=f981401f-8095-4290-92f7-c3abf8be6890

USA February 13 2023. On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter [1] to RightEye, LLC (RightEye), the …