Medical Devices; Medical Device Reporting; Annual Certification

The Food and Drug Administration (FDA) is amending its medical device manufacturer and distributor adverse event certification regulations. The revised certification requirements allow manufacturers and distributors to designate more than one certifying official, who would each sign a certification statement for his or her identified organizational component or site; amend the certification statement to minimize concerns relating to liability from unintentional reporting errors; and indicate that the certifying official is making the certification statements, to the best of his/her knowledge and belief. This action is being taken to help FDA carry out its public health protection responsibilities relating to medical devices. This action provides reporting entities with greater flexibility in the certification process while reducing the regulatory burden.