In Brief: Device third-party pilot expansion
This article was originally published in The Gray Sheet
Executive Summary
Device third-party pilot expansion: Addition of at least 30 higher-risk devices to the external review program is planned by FDA as a first installment of an expansion plan. More devices likely will be added later in the year. FDA receives a relatively large number of 510(k)s for the 30-plus devices and takes longer to review them than other devices already included in the pilot program. Guidance documents for the devices already exist or can be issued rapidly, agency staffers say...