FDA clarifies when a change to a device is a recall and when it is a product enhancement in a draft guidance released Feb. 22. The document also explains the reporting requirements for both recalls and product enhancements. Manufacturers often have trouble figuring out whether a change to a device meets the definition of a recall, the appropriate scope for a recall and when FDA should be notified of a recall – problems that "can result in delays in notifying the public about unsafe medical devices," FDA says. The agency explains that when a firm improves a device design, it does not necessarily mean that the existing device needs to be recalled; such changes may be characterized as product enhancements. Comments on the draft guidance are due May 23.
Regulatory News In Brief
FDA draft guidance explains the difference between recalls and product enhancements. Proposed rule on non-U.S. studies. More regulatory news.