The FDA has granted expedited access pathway designation to Second Sight Medical Products for its Orion cortical visual prosthesis system, according to a company press release.
The designation, given to select medical devices, is intended to help patients have more timely access to devices by expediting their development, assessment and review, the release said.
“These advantages potentially allow the FDA to approve Orion with fewer patients and with a shorter follow-up timeline, thus facilitating a faster entry of Orion into the commercial market,” Will McGuire, president and CEO of Second Sight, said in the release. “We are delighted about the opportunity for patients to have expedited access to Orion, once approved.”
In addition, a draft guidance document for a breakthrough devices program, which will replace the expedited access pathway after it is finalized, has been released by the FDA.
Through this designation, Orion will have greater interactive review for the investigational device exemption and premarket approval application, greater reliance on post-market vs. pre-market data collection, priority review and senior FDA management involvement, according to the release.