Devices

Breakthrough Device Program Effective: FDA

CDRH director of Ophthalmic, and Ear, Nose, and Throat Devices Malvina Eydelman says that since passage of the 21^st Century Cures Act, CDRH has received 94 requests for breakthrough devices treating a variety of conditions, and has granted 54 of them. Writing in an FDA Voice blog post, Eydelman says that in the Breakthrough Device Program, the interaction among specialists across disciplines representing the sponsor and FDA could lead to devices that have the potential to change patients’ lives without compromising safety or effectiveness.

The post relates the story of Second Sight Medical Products’ Orion Cortical Visual Prosthesis System, a brain implant for patients with blindness caused by damage to the optic nerve.

Eydelman says the company qualified for interactive and timely communication with FDA even before it embarked on a clinical trial to study the device in patients. “The early interactions resulted in the development of a flexible study design, review team support, and senior management engagement, all of which may allow a sponsor to evaluate complex, innovative technologies more efficiently,” she writes.

FDA says it was able to use this process to work closely with the company on a novel way to measure benefit and risk, clearing the way for Second Sight to proceed with a small clinical trial that will involve five patients at two sites.

Eydelman concludes that the Breakthrough Design program “shows FDA at its best, committed to patient access and willing to balance benefits and risks in a scientifically robust manner led by compassion and respect for the perspective of patients.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome