This event offers the opportunity to mingle with your colleagues while learning about the latest developments at the CDRH through a panel discussion. Topics to be explored include: the Software Pre-Cert pilot program; new digital health guidance, including clinical and patient decision support software guidance, benefit risk guidances and the expanded abbreviated 510(k) program guidance; TPLC reorganization in CDRH; the Medical Device Safety Action Plan; changes in inspections/program alignment; and Case for Quality.

Speakers

Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel FDA and Life Sciences, Environmental Health and Safety, Global Trade, Medtronic, and Member, FDLI Board of Directors
Carolyn A. Alenci, Associate, Duane Morris LLP
Moderated by Frederick R. Ball, Partner, Duane Morris LLP and Member, FDLI Board of Directors

Online registration is now closed. Please register for the event onsite.