RAPS Belgium Local Networking Group reposted this
Hope is not a regulatory strategy. I thoroughly enjoyed the lively exchange of ideas at the Next Generation Diagnostics Summit in Washington, DC this week. My key regulatory takeaway: - You may hope that the FDA's Final Rule on LDTs is overturned - You may hope that the FDA follows through on its intent to down-classify most IVDs - You may hope that the IVDR will be substantially revised But you must plan your regulatory strategy based on what is known. - Plan to submit your LDTs for FDA review - Plan for a PMA for your new companion diagnostic - Plan to comply fully with the IVDR #NGDx #IVD #IVDR #CDx #LDT