Developing a Spinal Plate Now or In the Near Future? If so, you may want to download the latest draft guidance from the FDA titled "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway". See link below. They've released this as a DRAFT only at this time in order to gain industry comments. But it shows that the FDA is definitely heading towards a performance pathway that does not require obtaining and testing predicate devices. This will be a major improvement and will likely speed up development and 510(k) submissions, since performance and safety targets will be known and easily available. I think these changes will be particularly helpful to small and startup companies.
https://www.fda.gov/media/130867/download
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