software as a medical device
The FDA clearance comes just three months after the company received EU MDR Class IIb certification for its configurable disease management platform.
With the abrupt transition to telehealth, the paradigm of care has shifted from legacy thinking to digital innovation
The new guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act.
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.
Companies planning an upcoming De Novo or 510(k) submission for their software medical device are eligible, but participation will not yield precertification.