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FDA offers tips for getting ophthalmic innovations to market
ORLANDO, Fla. — Transparency is the key to helping speed U.S. Food and Drug Administration approval of new ophthalmic products and devices, and utilizing some underused pathways also may help, a speaker said here.
"The best way to [speed approval] is to maximize the quality of the premarket submission," Malvina B. Eydelman, MD, director of the FDA's Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices, said at the Ophthalmology Innovation Summit.
"Ask for our input early in the development and actually utilize the input in the R&D and clinical trials," she said.
Dr. Eydelman also called attention to the FDA's de novo process, a system that she said is often overlooked. It can be used to help accelerate approval of devices that have not been marketed in the United States but have a safety profile and technology that are "reasonably well understood."
"This is a pathway that we at the FDA want to encourage," she said, noting guidelines are available at the FDA website. Openness and clarity, however, remain the most important tools for navigating through the system, she said.
"Consistency and transparency are very important key words," Dr. Eydelman said.
- Disclosure: Dr. Eydelman is the director of the FDA's Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices.