Home » CDRH Working on MDR Protocol in Response to OIG Evaluation
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
The GMP Letter
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