Since we will be in our nation’s capital this April, OIS is teaming up with the CDRH to create a unique Master Class focusing on Pathways for Expediting Ophthalmic Device Innovation.

The OIS@ASCRS Master Class, will feature CDRH staff members discussing novel mechanisms and pathways aimed at facilitating innovation. Some of these pathways include Digital Health Functionality Initiatives to foster innovation in ophthalmic devices, a decrease in total time to decision for 510(k) submissions, and providing early evaluation of small human clinical studies to help improve development strategies for expedited accessibility of certain products intended for unmet public health needs. Additionally, we incorporate patients’ perspectives into device development and evaluation process through improved use of patient reported outcomes (PROs) and patient preference information (PPI).

The discussion will enable attendees to have suitable resources to address scientific and regulatory challenges raised by innovative devices. CDRH is committed to have a product's timely progress to market without compromising safety or effectiveness with patients as the ultimate beneficiaries.