The FDA wants to help drug and device developers get their products approved and on the U.S. market faster and earlier.
A series of new programs and guidances appear to be working, at least for devices. In 2011, approval for a full IDE took a median of 442 days. In 2014, that same full IDE approval took a median of 101 days.
“If you have a device in development, come and talk to us early and often,” advised Malvina Eydelman, MD, director of the FDA Division of Ophthalmic Device Evaluation. “We have new tools like the Early Feasibility Study that allow us to hold your hand through the entire process as needed to get a product to market expeditiously.”
Dr. Eydelman outlined FDA’s new process designed to simplify and streamline the approval process during a panel discussion on “Getting to New Horizons.” The agency has new guidances on early feasibility studies that include some first in-human studies as a new guidance that defines MIGS for the first time.
“You have to remember that we have never before had a consensus on what MIGS means,” said Wiley Chambers, MD, supervisory medical officer in the FDA Division of Transplant & Ophthalmology. “MIGS could mean minimally invasive glaucoma surgery or it could mean micro-incisional glaucoma surgery. You can do a very invasive procedure using very small instruments. You can make a very large bleb through a 50-µm hole in the eye.”
Under a guidance issued in February 2014, MIGS is a minimally invasive glaucoma surgery. A MIGS device is “a type of IOP-lowering Device used to lower IOP using an outflow mechanism with either an ab interno or ab externo approach associated with little or no scleral dissection and minimal or no conjunctival manipulation.”