www.fdanews.com/articles/126898-revised-codes-for-device-problems-should-improve-trend-tracking
Revised Codes for Device Problems Should Improve Trend Tracking
May 7, 2010
New codes used to report problems related to devices should help CDRH improve its capability to track adverse event trends.
The revised codes — used
when submitting medical device reports to CDRH — went into effect last month. While some codes were eliminated, CDRH retained more than 60 percent
of the problem codes. “There was a feeling the codes were not as good as they could be,” Terrie Reed, a CDRH policy analyst, said.
The GMP Letter
The GMP Letter