This statistic shows the number of warning letters the Food and Drug Administration (FDA) sent concerning medical devices for fiscal years 2009 to 2017. In 2015, the FDA sent 168 warning letters to the appropriate responsible individual, manufacturer or facility informing them that their medical device was in violation of laws that the FDA enforces.
Number of warning letters the FDA sent concerning medical devices from 2009 to 2017*
* "A Warning Letter is a written communication from FDA notifying a responsible individual, manufacturer, or facility that the agency considers one or more products, practices, processes, or other activities to be in violation of the laws that FDA enforces. The Warning Letter informs the recipient that failure to take appropriate and prompt action to correct and prevent any future repeat of the violations could result in an administrative or judicial action. Although serious noncompliance is often a catalyst for issuance of a Warning Letter, the Warning Letter is informal and advisory."
Medical devices and radiation safety = CDRH (Center for Devices and Radiological Health).
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Food and Drug Administration. (January 17, 2018). Number of warning letters the FDA sent concerning medical devices from 2009 to 2017* [Graph]. In Statista. Retrieved November 10, 2024, from https://www-statista-com.ezproxy.canberra.edu.au/statistics/618769/fda-medical-device-warning-letters/
Food and Drug Administration. "Number of warning letters the FDA sent concerning medical devices from 2009 to 2017*." Chart. January 17, 2018. Statista. Accessed November 10, 2024. https://www-statista-com.ezproxy.canberra.edu.au/statistics/618769/fda-medical-device-warning-letters/
Food and Drug Administration. (2018). Number of warning letters the FDA sent concerning medical devices from 2009 to 2017*. Statista. Statista Inc.. Accessed: November 10, 2024. https://www-statista-com.ezproxy.canberra.edu.au/statistics/618769/fda-medical-device-warning-letters/
Food and Drug Administration. "Number of Warning Letters The Fda Sent concerning Medical Devices from 2009 to 2017*." Statista, Statista Inc., 17 Jan 2018, https://www-statista-com.ezproxy.canberra.edu.au/statistics/618769/fda-medical-device-warning-letters/
Food and Drug Administration, Number of warning letters the FDA sent concerning medical devices from 2009 to 2017* Statista, https://www-statista-com.ezproxy.canberra.edu.au/statistics/618769/fda-medical-device-warning-letters/ (last visited November 10, 2024)
Number of warning letters the FDA sent concerning medical devices from 2009 to 2017* [Graph], Food and Drug Administration, January 17, 2018. [Online]. Available: https://www-statista-com.ezproxy.canberra.edu.au/statistics/618769/fda-medical-device-warning-letters/
