CDRH Working on MDR Protocol in Response to OIG Evaluation

Devicemakers may see more action taken on late and incomplete medical device reports (MDRs) as CDRH develops a protocol addressing concerns raised in a new report by the HHS Office of Inspector General (OIG). 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 of follow-up actions.
The GMP Letter