Dexcom says the FDA issued a warning letter over its reporting of adverse events associated with its continuous glucose monitors.
Dexcom Inc. (NSDQ:DXCM) said the FDA flagged its adverse event reporting system for not being compliant with new medical device reporting rules.
The federal watchdog agency issued a warning letter to San Diego-based Dexcom, which makes continuous glucose monitors for diabetics, after an inspection in November 2013, according to a press release.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1jqR96X
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