Why can’t we apply for a 510k approval - it will still allow Rap to be a screening tool so isn’t this the logical approach to take for now - Get Rap out there to at least help with screening to American Clinics desperately needing this help and show them how good the product is - the Benefit is far superior to the risk
Ann: Update on US FDA De Novo Classification Request, page-317
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
