Circulatory Technology Inc. received a Form 483 for failing to submit a medical device report (MDR) in a timely manner, properly evaluate an MDR event, establish a design history file, establish adequate design plans, and properly investigate complaints.

First, the inspector said that Circulatory Technology failed to submit an MDR report within 30 days of becoming aware of information suggesting that a marketed device had malfunctioned and likely would cause or contribute to a death or serious injury if the malfunction recurred.

The Form 483 also states that the company did not evaluate MDR events in accordance with relevant regulations. Specifically, it was notified of two MDR reports for a device but did not open any complaint files or investigate the reported MDR events for the device. — Jeff Kinney