Respironics, Inc. – FDA Warning Letter, Jun 24, 2011

On October 11, 2011, the FDA issued a Warning Letter to Respironics, Inc. following an inspection from June 1-24, 2011, at their Murrysville, PA facility. The inspection found that Respironics' Trilogy 100, 200, and 202 continuous ventilators, classified as devices, were misbranded under 21 U.S.C. § 352(t)(2) due to failures in Medical Device Reporting (MDR) as required by 21 CFR Part 803.

Key violations included: 1. **Failure to submit MDRs:** Respironics failed to submit MDRs within 30 days for device malfunctions, specifically for life-sustaining ventilators, where recurrence could cause death or serious injury, as required by 21 CFR Part 803.50(a)(2). The company's revised reportability criteria, limited to "loss of therapy," were deemed inadequate. 2. **Inadequate MDR Procedure:** The firm's revised MDR Procedure, titled (b)(4), failed to meet 21 CFR Part 803.17 requirements by: * Not establishing timely identification, communication, and evaluation systems for MDR events, including patient follow-up. * Incorrectly limiting reportability criteria for ventilator failures. * Lacking a