Micromed Technology, Inc – FDA Warning Letter, Aug 6, 2009

On July 27-August 6, 2009, an FDA inspection of MicroMed Technology, Inc. in Houston, Texas, revealed that their DeBakey VAD Child devices are misbranded under section 502(t)(2) of the Act, due to failure to furnish required material or information per section 519 and 21 CFR Part 803 (Medical Device Reporting regulation).

Significant deviations include: 1. Failure to submit adverse event reports within 90 days as required by 21 CFR 803.19(e), despite participation in the INTERMACS registry. 2. Failure to report to the FDA within 30 calendar days information suggesting the device caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). 3. Failure to report to the FDA within 30 calendar days information suggesting the device malfunctioned and would likely cause or contribute to death or serious injury if the malfunction reoccurred, as required by 21 CFR 803.50(a)(2). 4. Failure to implement written MDR procedures for timely and effective identification, communication, and evaluation of events subject to MDR requirements, as required by 21 CFR 803.17.

The FDA requires prompt corrective action. Failure to comply may result in