Device, software, or process change — do you need a new submission? This engagement applies FDA's 2019 Deciding When to Submit a 510(k) guidance and the PCCP framework to your specific change, and delivers a written determination with regulatory rationale you can put in your DHF.
Device, software, or process change — do you need a new submission? This engagement applies FDA's 2019 Deciding When to Submit a 510(k) guidance and the PCCP framework to your specific change, and delivers a written determination with regulatory rationale you can put in your DHF.