CardioMEMS, Inc. – FDA Warning Letter, Nov 30, 2011

An FDA inspection of CardioMEMS, Inc. from November 15-30, 2011, revealed serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects) concerning their CHAMPION clinical study (IDE G060187) for the CardioMEMS HF Pressure Measurement System. The inspection aimed to ensure compliance and data validity. Key violations include: 1) Failure to submit an accurate investigational plan and protocol (21 CFR 812.20(b)(2), 812.25(b)), as the firm made clinical recommendations to investigators not detailed in the approved protocol, compromising study validity and results. 2) Failure to maintain accurate, complete, and current correspondence records (21 CFR 812.140(b)(1)), evidenced by discrepancies in emails to FDA and an altered Device Return Form, raising concerns about data integrity and subject safety. 3) Failure to provide investigators with necessary information (21 CFR 812.40), as the firm evaluated a study subject at its facility without informing the clinical investigator or obtaining IRB review. 4) Failure to include a complete description of procedures in the informed consent (21 CFR 50.25(a)(1)), specifically omitting the firm's clinical recommendations to investigators. These deficiencies raise significant questions about the reliability of effectiveness data for PMA P100045 and the safety/effectiveness of the device without the firm's intervention. CardioMEMS must provide documentation of corrective actions, including projected completion dates and a monitoring plan, within 15 working days to prevent further regulatory action.