All links provided below will direct you to the respective resource on the FDA website.
I am working on an in vitro diagnostic - where can I get started?
Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices Draft Guidance for Industry and Food and Drug Administration Staff –November 2018
I am working on a digital health technology - where can I get started?
I am working on a companion diagnostic device where - can I get started?
I am working on a drug/device combination product - where can I get started?