RE: FDA Approval11 Sep 2019 10:34
I had a look back at the december 2018 update. -pasted the main point below ie that the 90 days is a standard but not a legal requirement. So the approval may be soon or not so soon- I suppose it was a difficult new technology and the FDA had the reduction in funding so the excuse for the delay is reasonable. But should be pretty soon now ,and I suspect they will hold back on the RNS re the results for a while awaiting the approval. Good luck all
This represents the normal application process with the FDA for a 510k. The manufacturer submits a data package for review. The FDA examines it for completeness, then starts working on it. At any point they can 'stop the clock' to ask questions, and that clock restarts when the manufacturer submits answers. The FDA is evaluated against a standard, and processes 95% of 510k's within 90 days of the FDA review time. Given that the StoneChecker application has now been with them for over half that time it appears that while approval may be forthcoming at the end of the year, it is more likely that the FDA may not complete their review of the package until Q1 2019.