Can European studies be used to support approval of ophthalmic devices in the United States?
Malvina B. Eydelman, MD
SENIOR MEDICAL ADVISOR
Division of Ophthalmic and Ear, Nose and Throat Devices
Center for Devices and Radiological Health
Food and Drug Administration
VENUE:
Auditorium VI/ VII
This lecture will describe how ophthalmic devices are regulated in the United States (US). US Food and Drug Administration's (FDA) role in ophthalmic devices will be discussed in a comprehensive manner by an FDA expert. Criteria will be defined for utilizing European data to support ophthalmic device approval in US.
