FDA Emphasizes Pre-Submissions For Neuro Devices
Make pre-submissions early and as complete as possible to ensure speedy review and thorough answers for neurological devices, FDA staff says.
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More specific details have emerged about the agreement "in principle" announced last week by FDA and industry negotiators on the next round of the medical device user-fee program, which will extend from fiscal years 2018 through 2022.
The guidance, which is very similar to a proposed version from last year, updates the interactive review program, and describes three relatively new points of communication between FDA and a device sponsor during the review process.
It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one.