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Focus on Regulation

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH), the FDA center that governs medical devices, reached an 8 year low, down 50% from FY 2015. The drop in CDRH issued warning letters coincided with a significant rise in the number of warning letters issued by the Center for Drug Evaluation and Research (CDER), which more than doubled from FY 2015. This is the first time in at least 8 years that the number of annual (FY) warning letters issued by CDER exceeded the number issued by CDRH. It is interesting to note that the number of 483 observations issued for devices remained much higher than for drugs, despite many more warning letters being issued for drugs compared to devices.

The Agency did not report significant fluctuations in other FDA enforcement activities. For instance, total recalled products and the number of 483s issued during an inspection were consistent with prior years across both FDA centers.

Looking at other CDRH specific enforcement activities, the number of Class II and Class III Device inspections was consistent with the prior 3 years reported. There was a slight drop (6.2%) in the number of CDRH BIMO inspections conducted in FY 2016 compared to FY 2015. This is consistent with a steady downward trend in CDRH BIMO inspections since FY 2013. The number of 483s issued during BIMO inspections by any center also fell 14% compared to FY 2015. Data on the number of 483s issued during CDRH BIMO inspections was not available.

Warning letters

* Data published by FDA, available at http://www.fda.gov/ICECI/EnforcementActions/ucm247813.htm.

483s issued

* Data published by FDA, available at http://www.fda.gov/ICECI/Inspections/ucm250720.htm.

Total recalled products

* Data published by FDA, available at http://www.fda.gov/ICECI/EnforcementActions/ucm247813.htm.

Number of Class II and Class III Device Inspections (FY 2013-2016)

* Data published by FDA, available at http://www.fda.gov/AboutFDA/Transparency/track/ucm204013.htm.

Number of Medical Device BIMO Inspections (FY 2013-2016)

* Data published by FDA, available at http://www.accessdata.fda.gov/scripts/fdatrack/view/track.cfm?program=ora&id=ORA-Medical-Device-Bioresearch-Monitoring-BIMO-inspections.

483s Issued During BIMO Inspection by Any Center (FY 2013-2016)

* Data published by FDA, available at https://www.fda.gov/ICECI/Inspections/ucm250720.htm.