Design control regulation

The Food and Drug Administration will be implementing the new GMPs for Medical Devices in June 1997. One of the significant addition to the New GMPs for Medical Devices with be part 830.30 Design Controls. Since 1984, the agency has recognized the lack of Design Controls as a significant cause for device recalls. Product design is the foundation for product development and if there is a failure in the product foundation, the product can not satisfy its intended application. It is concluded that Design Control has a significant impact on the ultimate success or failure of a new product. The value added by a manufacturer dedicating greater attention to the front end design of a new product is the less likely occurrence of unanticipated problems resulting in device recalls