Assertion: program's goal | /r/CapableOf | preserve statutory standards
Facets:
value: for 510(k) clearance
type: PURPOSE
value: for de novo marketing authorization
type: PURPOSE
value: for premarket approval
type: PURPOSE
Source sentences:
text: The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.