Expert Offers Advice on Reporting Recalls

Device manufacturers must report voluntary recalls or corrections to the FDA if the action was initiated to reduce a “risk to health” — even if the event was caused by a user error, an expert advises.

When manufacturers recall a device, they should know when and what to report to avoid trouble with the FDA. Communicating with the agency when preparing for a recall could prevent a Form 483 or a warning letter, Michael Barlie, managing partner of Barlie & Associates, said at an FDAnews audioconference.

Class I and II recalls represent the most concern to public health and must be reported. While Class III recalls do not require events to be reported, Barlie advised devicemakers to notify the FDA anyway. “You can tell the coordinator you’ve decided that this is a Class III action, but in the spirit of cooperation, you’re letting him know about the action nonetheless,” he said.
The GMP Letter