Device Terms (18)
18 terms in this category. Navigate definitions and jump to related workflows.
De Novo Classification Request(De Novo)
A pathway for novel low-to-moderate risk medical devices that lack a predicate but do not require PMA-level review.
Design Controls
Systematic practices applied during product design and development to ensure devices meet user needs and intended uses.
DESIGN SPACE
DESIGN SPACE is used to support defensible premarket and postmarket device decisions.
DEVICE History RECORD
DEVICE History RECORD is used to support defensible premarket and postmarket device decisions.
DEVICE MASTER RECORD
DEVICE MASTER RECORD is used to support defensible premarket and postmarket device decisions.
DHF(DHF)
DHF is an important device-regulatory concept for pathway selection, evidence strategy, and compliance.
MAUDE(MAUDE)
MAUDE is used to support defensible premarket and postmarket device decisions.
Medical Device Reporting(MDR)
FDA mandatory reporting requirements for manufacturers and user facilities when medical devices may have caused or contributed to death or serious injury.
