The Center for Device and Radiologic Health at the US Food and Drug Administration (FDA) has developed several regulatory programs for innovative ophthalmic devices. The programs, which are summarized later in this article, are designed to assist in developing these technologies.
The Pre-Submission Program offers access to regulatory officials to discuss and collaborate on specific regulatory issues that an applicant might face in bringing novel technology to market. These submissions are free and can provide written and in-person feedback on questions the applicant provides to the FDA.1 The Pre-Submission Program can identify issues early, often before any formal submissions are made, and help guide the development of nonclinical and clinical work. Additionally, applicants benefit from the accumulated institutional knowledge of the FDA, which can lead to efficient data generation and regulatory pathways, ultimately helping to bring devices to patients sooner.
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Brodie F, Nguyen T, Eydelman M. US Food and Drug Administration Regulatory Programs for Innovative Technologies. JAMA Ophthalmol. Published online September 26, 2019. doi:10.1001/jamaophthalmol.2019.3708
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