https://www.fda.gov/regulatory-information/laws-enforced-fda/selected-amendments-fdc-act
https://www.fda.gov/combination-products/classification-and-jurisdictional-information/intercenter-agreement-between-center-biologics-evaluation-and-research-and-center-devices-and
Product jurisdiction is determined by the Office of Combination Products https://www.fda.gov/about-fda/office-special-medical-programs/office-combination-products
https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
https://www.fda.gov/vaccines-blood-biologics/510k-process-cber/devices-regulated-center-biologics-evaluation-and-research https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance