The FDA is rethinking efficiency of the 510(k) review process. The changes detailed in the FDA’s draft guidance could increase use of the special 510(k) program by opening it to a wider range of changes. FDA proposals allow certain changes to indications for use to be reviewed under special 510(k) filings as part of regulatory revisions that expand the program to cover design and labeling amendments.
Certain limitations will apply to the use of the program; changes that require supportive performance data will be ineligible for the program, but the exception is if the change can be evaluated using well-established methods and the performance data needed to show substantial equivalence can be reviewed in summary or risk-analysis format.
Feedback on the draft guidance will be accepted until Nov. 27, 2018.
IMDRF committee to tackle cybersecurity threats
The International Medical Device Regulators Forum (IMDRF) has added a new cybersecurity working group chaired by the U.S. and Canada. Established in 2011 to harmonize regulatory standards across different countries, the IMDRF includes the U.S., European Union, China, Japan, South Korea, Russia, Singapore, Australia, and Brazil.
According to Jeff Shuren, director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA) and a member of the IMDRF’s management committee, the new working group will write guidance to define cybersecurity and related terms, and will clarify that cybersecurity is a shared responsibility.
FDA, DHS and cybersecurity
The U.S. Food and Drug Administration (FDA) and the U.S. Department of Homeland Security (DHS) released a memorandum of agreement about implementing a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.