August 16, 2018

Media Inquiries

  Deborah Kotz
  301-796-5349

“The FDA is taking steps to advance innovation and surveillance for medical devices through the timely implementation of three new initiatives related to the recent user fee re-authorization,” said FDA Commissioner Scott Gottlieb, M.D. “First, we’re streamlining the process for the reporting of device malfunctions through a summary reporting program. This will allow us to more efficiently detect potential safety issues and free up resources to better focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices. Another way we’re prioritizing our resources on devices that pose higher risks to public health is by publishing a proposed list of device accessories that we believe are suitable for re-classification to the lowest-risk category of devices (class I). We are seeking public comment that will inform our thinking as we finalize this list. We’ve also published a draft guidance to provide more clarity concerning the FDA’s issuance of Certificates to Foreign Government requested by firms exporting FDA-regulated medical devices from the U.S. The guidance clarifies the circumstances under which the FDA may deny a request for a certificate and explains how a firm whose request is denied can request a review of that denial.”

As committed in the MDUFA IV agreement, the FDA today announced it has finalized a program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form--the Voluntary Malfunction Summary Reporting Program. This voluntary program, which is informed by public comments received by the FDA, allows manufacturers to report certain device malfunctions in summary form on a quarterly basis, rather than on an individual basis, for certain product codes. The FDA previously piloted a version of the program and identified several benefits, including more efficient review and understanding of malfunction issues and, because summary reports bundle similar malfunction events for a device, improved ability to identify related adverse events and trends. These benefits can be achieved without compromising effective surveillance and public availability of postmarket information about the devices. To that end, the program includes key limitations: It does not apply to reportable death or serious injury events, which are still required to be sent to the FDA within 30 calendar days of the manufacturer becoming aware of those events. Devices under product codes in existence for less than two years are not eligible for the program. The FDA also may still require individual malfunction reports—instead of summary reports—for devices that are eligible for the program, such as when individual reports are necessary for specific devices or from a specific manufacturer in order to address a public health issue.

To fulfill another requirement of the FDA Reauthorization Act of 2017 (FDARA), the FDA has posted a Federal Register notice and opened a public docket requesting comments on a proposed list of accessories for which general controls will provide a reasonable assurance of safety and effectiveness and which the FDA may classify as class I, low-risk devices. Finalizing the list of accessories suitable for classification into class I will reduce the regulatory burden for those devices and help support the agency’s risk-based approach so that resources can be better focused on the products that pose the most risk to patients.

The FDA also issued draft guidance today titled “Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices,” which explains the denial process for Certificate to Foreign Government (CFG) requests for medical devices exported from the U.S. This guidance clarifies the reasons the FDA may deny a request for a CFG, and describes the information that the FDA will provide to a firm whose request for a CFG for a device is denied as well as the process for requesting a review of that decision. This guidance applies only to CFGs for devices that are approved or cleared for marketing in the U.S. or are exempt from premarket submission requirements. It is intended to provide clarity for those seeking these certificates, and the FDA will consider comments submitted about the draft guidance before determining a final approach.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.