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.
"The warning letter relates to deficiencies in filing medical device reports (MDRs) involving the company’s continuous glucose monitoring system," according to the release.
Dexcom is not up to date with new MDR rules the FDA instituted last year, the company said, but plans to be in compliance by the end of next month.
"Before the end of April 2014, Dexcom expects to submit all materials necessary to demonstrate to the FDA’s satisfaction that the company is in compliance with its reporting obligations in an effort to resolve any remaining deficiencies and close out the warning letter in due course," Dexcom said.
The FDA didn’t impose any sanctions in the warning letter, according to the release. Dexcom said it doesn’t expect the warning to affect its current operations or any of its pending or future bids for clearance or approval from the agency.
DXCM shares were trading at $43.38 apiece as of about 11:10 a.m. today, up 0.7%.
