AdvaMed Device Submissions Workshop In Brief
New 510(k) paradigm: Level 2 guidance document on 510(k)s is expected to be released by the end of the summer, Office of Device Evaluation Premarket Notification Staff Director Heather Rosecrans tells attendees at AdvaMed's device submissions workshop held June 6-7 in Rockville, Maryland. "We're right at the process of updating the new paradigm, and that's going to go through the GGP [good guidance practices] process. We're going to consider the truthful and accurate...statement in place of the declaration of conformity...with design controls, because there's no end and no beginning and there has been some confusion." Rosecrans highlighted one change for manufacturers submitting 510(k)s: "validation will have to be completed prior to going to market with your device"...
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Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.