Fda Warning Letters 2011 Medical Devices

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

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

In certain situations, CDRH may become aware that regulated industry maybe promoting a medical device product in a manner that potentially violates the Federal Food, Drug, and Cosmetic Act and its implementing regulations. CDRH may issue an "It Has Come to Our Attention" Letter (IHCTOA Letter) to regulated indu… See more

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

Posted Date Letter Issue Date Company Name Issuing Office Subject …

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 …

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

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

CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical Systems Corporation, and one of its subsidiaries, Aizu Olympus Co, …

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.

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 …

Warning Letters and Notice of Violation Letters to …

https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies

Untitled Letters 2021. These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion's untitled letters. The …

Medical Devices FDA Warning Letters

https://starfishmedical.com/blog/medical-devices-fda-warning-letters/

From December 2011 to February 21, 2012, the Agency issued 30 warning letters to medical device companies; 5 were related to the same product being advertized off the label. Noted …

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 …

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 …

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

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

Safety Communications | FDA

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

Letters to Health Care Providers | FDA

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

Warning Letters and Notice of Violation Letters to …

Medical Devices FDA Warning Letters

FDA Issues Two Warning Letters to Leading …

Olympus Medical Systems Corporation - 649726

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