FDA WARNING_LETTER - Power Medical Interventions Incorporation - May 21, 2008

An FDA inspection of Power Medical Interventions Incorporated, manufacturer of surgical cutting and stapling devices, from April 7 to May 21, 2008, revealed significant violations. The firm's devices were found to be adulterated under 21 U.S.C. § 351(h) for non-conformity with the Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required Medical Device Reporting (MDR) information (21 CFR Part 803). QS violations included failures in establishing and maintaining complaint handling procedures, reviewing and investigating complaints, ensuring timely complaint processing, effective Quality System management, and adequate design validation. MDR violations encompassed failures to report deaths/serious injuries and malfunctions within 30 days, maintain complete MDR event files, implement written MDR procedures, and conduct complete event investigations. Although the firm submitted multiple responses, compliance will be verified in a future inspection. The FDA requires prompt corrective action within fifteen working days, including documentation and a timetable for longer corrections. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.