FDA Focus on More Efficient Processing Yields Faster Decisions

FDA Focus on More Efficient Processing Yields Faster Decisions
SAN FRANCISCO — The U.S. Food and Drug Administration has been criticized for its ponderous movement of potential drugs and medical devices through the approval process. Recognizing this criticism, and following implementation of the Medical Devices User Fee and Modernization Act of 2002 and subsequent internal reevaluations and reorganizations, the FDA approval process for innovative technologies has been gaining speed since 2010.

“We believe the U.S. is and should remain the leading innovation leader,” Malvina B. Eydelman, MD, director of the FDA Division of Ophthalmic and Ear, Nose and Throat Devices, said at the Ophthalmology Innovation Summit meeting here.

Improvements have included streamlining premarket review; assuring predictable and consistent decision making, improving quality of submissions and clinical trial data; promoting greater transparency, interaction and collaboration between the FDA and industry before and during the premarket reviews; and improving the FDA’s understanding of new device technologies, Eydelman said.

Consequently, in Eydelman’s department, the average time to clear a 510(k) has dropped about 30% since 2010, and the average time to reach a decision on a premarket approval is about one-third less, she said. Furthermore, the percentage of filed premarket approvals that are approved, which were steadily declining since 2005, has risen more than 20% since 2010, she said.

Disclosure: Eydelman is director of the FDA Division of Ophthalmic and Ear, Nose and Throat Devices of the U.S. Food and Drug Administration.

Article was originally posted at Healio.

SHARE THIS ARTICLE WITH YOUR COLLEAGUES:

RECOMMENDED FOR YOU

How Omega Ophthalmics Hopes to Redefine Use of the Capsular Bag with the Gemini Refractive Capsule

How Omega Ophthalmics Hopes to Redefine Use of the Capsular Bag with the Gemini Refractive Capsule

Glaukos' Bid for Avedro: What's Next

A Closer Look at Glaukos’ Bid for Avedro

OIS@ASRS Reporter's Notebook: Three Things Learned at OIS@ASRS About What Funders Want, Going Global, and AI

OIS@ASRS Reporter’s Notebook: Three Things Learned at OIS@ASRS About What Funders Want, Going Global, and AI

Recent Moves Show How Zeiss Is Positioning Itself for a New Era in Ophthalmology

Recent Moves Show How Zeiss Is Positioning Itself for a New Era in Ophthalmology

National Vision and Eye Health Surveillance System Gears Up for September Launch

National Vision and Eye Health Surveillance System Gears Up for September Launch

OIS@ASRS at the Ritz-Carlton Chicago: An In-depth Look at the Retina Space

OIS@ASRS at the Ritz-Carlton Chicago: An In-depth Look at the Retina Space

About The Author

Tom Salemi

Tom serves as Content Director for Healthegy, joining the company in 2014, to create and manage a new line of podcasts, publications and other editorial products. At Healthegy, Tom hosts the OIS Podcast and MedtechTalk, contributes to the Engage and Eye on Innovation newsletters and assists in the agenda development of new and existing conferences.

SUBSCRIBE TO OUR NEWSLETTER

Get The Latest News In Opthalmologic Innovation To Your Inbox.

We respect your privacy and will never send you spam.

Something went wrong. Please check your entries and try again.