DexCom Receives FDA Warning Letter for Administrative Deficiencies in its MDR Reporting
SAN DIEGO--(BUSINESS WIRE)--DexCom, Inc. (NASDAQ:DXCM) announced today that it has received a warning letter from the U.S. Food & Drug Administration (FDA) resulting from a November 2013 inspection of the Company’s facility in San Diego, California by the FDA’s Los Angeles District Office. The warning letter relates to deficiencies in filing medical device reports (MDRs) involving the Company’s continuous glucose monitoring system.
Regulations related to MDR reporting were updated by the FDA in July 2013, and during the inspection, the FDA determined that the Company was not compliant with these recent updates. There were, however, no sanctions levied by the FDA, nor does the warning letter impact the Company’s ability to manufacture and sell its G4 Platinum systems and sensors. Furthermore, the warning letter does not affect any of the Company’s pending or future submissions for product approvals. 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.
About DexCom, Inc.
DexCom, Inc., headquartered in San Diego, California, is developing and marketing continuous glucose monitoring systems for ambulatory use by patients and by healthcare providers in the hospital.
Cautionary Statement Regarding Forward-Looking Statements
DexCom is a medical device company with a limited operating history. Successful commercialization of the company’s products is subject to numerous risks and uncertainties, including a lack of acceptance in the marketplace by physicians and patients, the inability to manufacture products in commercial quantities at an acceptable cost, possible delays in the company’s development programs, the inability of patients to receive reimbursement from third-party payors and inadequate financial and other resources. Certain of these risks and uncertainties, in addition to other risks, are more fully described in the company’s annual report on Form 10-K for the year ended December 31, 2013, as filed with the Securities and Exchange Commission on February 20, 2014.
Contacts
DexCom, Inc.
Steven R. Pacelli
Executive Vice President, Strategy and Corporate Development
(858) 200-0200
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