CDRH
Although still a work in progress, the new center will reportedly help coordinate digital health projects within the agency while providing expertise to external stakeholders.
Roche, J&J regulatory leads weigh in on Pre-Cert's progress, challenges of regulating digital health
At BIO 2019 in Philadelphia, a panel of industry experts discussed their experiences with the FDA's pilot program; ambiguities in drug, device and software pathways; and the hurdles digital health regulation has yet to properly address.