CDRH Working on MDR Protocol in Response to OIG Evaluation
In its response to the report, the FDA says CDRH’s implementation of the FDA Adverse Event Reporting System by the end of 2010 will allow for more extensive documentation on follow-up actions. It also will permit the center to more readily identify late and incomplete MDRs.
The OIG is critical of CDRH’s review of MDRs, noting it is not using the reports in a systematic manner to address safety concerns about devices.
Since CDRH analysts document little of their review of an MDR, it is difficult to trace the center’s response, such as inspections, to an individual
event, according to the report that recommends CDRH adopt more stringent MDR protocols.
The GMP Letter