Solutions Circles Know Before You Go: • Tickets are required and can be picked up at the Solutions Circle check-in desk 20 minutes before start (first-come, first-served). • Max 30 participants per session. Seats cannot be held in between sessions. • Arrive early. Your seat is only held for 3 minutes after a session starts, then released to standby attendees. • Open to full conference registrants only - have your badge ready. • Located in the Exhibit Hall, booth 200.
Description: When the FDA sends an Additional Information Request (AIR) Letter for a 510(k) submission, the sponsor has 10 days to schedule a call with the FDA to clarify any questions regarding the deficiencies. Understanding the FDA’s deficiency is the first step in ensuring that FDA’s concern is being effectively addressed by the sponsor’s response. Although the FDA does not provide specific guidance on the best practices for these 10-day conference calls, this solution circle discussion will offer a valuable platform for industry professionals to exchange insights. Participants will share their experiences and recommendations on effectively conducting these calls.
Learning Objectives:
Upon completion of this session, participants should be able to learn tips for successful 10 day conference call.
Upon completion of this session, participants should be able to develop effective strategies for AI response.
