Recalls Will Play Key Role in Device Industry Going Forward

As medical devices become more complex and the FDA increases the effectiveness of its postmarketing surveillance, success in handling product recalls is going to become a key business activity for devicemakers, according to Kimber Richter, deputy director of medical affairs for CDRH’s Office of Compliance.

“We’re going to see recalls becoming more and more important,” Richter said last month at the Food and Drug Law Institute’s Surviving Medical Device Recalls eConference. “Successfully handling a recall is one of the key activities that a firm is going to have to do to assure successful future business, as well as to maintain the safety of their users and patients.”

Part of Richter’s responsibilities at the FDA is assessing the risk of product corrections to classify recalls. Companies should realize the agency needs information to ensure a particular classification is correct, Richter said.

The information provided should include both positive and negative mitigating factors, as well as a risk assessment that should be prepared with input from a physician experienced with the use of the product and in risk evaluation, Richter said. In situations where there is a lack of information, the FDA usually will assume the worst and upgrade the severity of the product correction, he said.