You are invited to attend the upcoming Society of Toxicology (SOT)-sponsored webinar hosted by Ocular Toxicity and Medical Device/Combination Product Specialty Sections (OTSS and MDCPSS) of the SOT. The details are provided below. Iuvo’s own Dr. Kathleen Krenzer is the President of the Ocular Toxicology Specialty Section of the Society of Toxicology.
Title: Biological Risk Assessments for Ocular Medical Devices
Speaker: Simona Bancos, Ph.D., Center for Devices and Radiological Health, U.S. Food and Drug Administration
Time: Wednesday, August 28th at 12:30 pm – 1:30 pm, eastern standard time
Presentation Abstract: This webinar will focus on reviewing the changes to the International Standard Organization (ISO) Fifth edition 10993-1:2018 and whether these changes have an impact on ophthalmic device biocompatibility assessments and on 2016 FDA Biocompatibility Guidance. The discussion will include an overview of relevant vertical standards and FDA guidance documents for ophthalmic devices including ISO 11979-5 Ophthalmic implants — Intraocular lenses- Part 5: Biocompatibility and Premarket notification (510(k)) FDA guidance document for daily wear contact lenses. The applicability of chemical characterization to the biological evaluation of ophthalmic medical devices will also be discussed.
The webinar is open to anyone, including non-members of SOT or MDCPSS/OTSS. Please feel free to forward the event information to your interested colleagues.