FDA warning letters over medical devices 2009-2017

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*

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Release date

January 2018


United States

Survey time period

FY 2009 to FY 2017

Supplementary notes

* "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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Statistics on "Pharmaceutical and medical device recalls in the U.S."

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