Topics covered in this session: Shawn Stevens & Susan Linn: - Recall reporter database - general recall trends - Speed of recalls historically. Why is it not as fast as ideal? What influences speed. - Recall contact data affects speed of confirmed notified - How methods of contact can reduce risk - Template for recall communications. FDA approval. - Recall communications audit trail Dr. Ostroff: - Significant recalls that occurred while I was at FDA - and some of the issues that arose related to those recalls Erik Mettler: - FDA ANPR going out regarding opening recalls. Can speak to how regulation may need to be changed. - What does it mean to be recall ready? - Effective checks - how do audit trails affect the need to do them? - RFR - do I need to report? Roundtable discussion > Town Hall Q&A: Open to questions from the audience