September 25, 2007 -- As medical devices become more complex and the FDA increases the effectiveness of its postmarketing surveillance, success in handling product recalls will become a key business activity for devicemakers, according to Kimber Richter, deputy director of medical affairs for the Center for Devices and Radiological Health's (CDRH) Office of Compliance. "We're going to see recalls becoming more and more important," Richter said 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 includes assessing the health risk of defective products, used in determining a recall's classification. Companies should realize the agency needs information to ensure a particular classification is correct, Richter said.
The information firms provide should include both positive and negative mitigating factors, as well as a risk assessment that should be prepared with input from a physician experienced in the use of the product and in risk evaluation, Richter said. In situations where there is a lack of information, the FDA will usually assume the worst and upgrade the severity of the product correction, she said. "Sometimes firms come back and they're shocked. They think our risk assessment is too high and, in fact, it's based on the lack of information," Richter said. "If we go back and ask for further information, it helps to provide it very quickly so that we can get our risk assessment done as accurately as possible."
Richter highlighted the new health hazard evaluation form CDRH uses in determining a recall's classification, either as Class I, representing the most serious risk to public health, Class II or III. The form is posted on the Office of In Vitro Diagnostic Devices Evaluation and Safety website.
Source: MQN Weekly Bulletin
