Investor Presentaiton

● ● IMDRF International Medical Device Regulators Forum STREAMLINING PREMARKET REVIEW: QUALITY 510(k) (QUIK) REVIEW PROGRAM PILOT "Turbotax" for 510(k) Sponsor completes formatted eSubmission In return, CDRH will: • • • Skip RTA phase Commit to interactive review without hold Reduce FDA review time by 1/3 turbotax. Deluxe Intuit turbotax Federal Returns | Federal E-File State Returns Deluxe Maximize Your Deductions Launched Pilot (selected product codes) September 2018 8

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