AAMI 2018 Conference & Expo

Sessions Speakers Exhibitors Floor Plan Buzz

FDA Action on Device Service: What You Need to Know and Do (Room CC, 103AB)

The FDA Reauthorization Act of 2017 required the agency to draft a report to the Congress and public “on the continued quality, safety, and effectiveness of devices … with respect to servicing.” That report is due May 15, 2018. After issuing the report, the FDA may issue an Advance Notice of Proposed Rulemaking (ANPR) on how it plans to regulate all device servicing, impacting both manufacturers and third-parties (including in-house teams). Hear from an FDA representative on its report and plan, and analyses and insights from other panelists.