Device Terms (18)

18 terms in this category. Navigate definitions and jump to related workflows.

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Showing 18 terms

1 terms

510(k) Premarket Notification(510(k))

A premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed predicate device.

Medical Devices

2 terms

Adaptive TRIAL DESIGN

Adaptive TRIAL DESIGN is an important device-regulatory concept for pathway selection, evidence strategy, and compliance.

Medical Devices

AUDIT TRAIL

AUDIT TRAIL is used to support defensible premarket and postmarket device decisions.

Medical Devices

1 terms

Center for Devices and Radiological Health(CDRH)

CDRH is the FDA center that regulates medical devices and radiation-emitting electronic products in the United States.

Medical Devices

6 terms

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.

Medical Devices

Design Controls

Systematic practices applied during product design and development to ensure devices meet user needs and intended uses.

Medical Devices

DESIGN SPACE

DESIGN SPACE is used to support defensible premarket and postmarket device decisions.

Medical Devices

DEVICE History RECORD

DEVICE History RECORD is used to support defensible premarket and postmarket device decisions.

Medical Devices

DEVICE MASTER RECORD

DEVICE MASTER RECORD is used to support defensible premarket and postmarket device decisions.

Medical Devices

DHF(DHF)

DHF is an important device-regulatory concept for pathway selection, evidence strategy, and compliance.

Medical Devices

1 terms

GUDID(GUDID)

GUDID is an important device-regulatory concept for pathway selection, evidence strategy, and compliance.

Medical Devices

2 terms

MAUDE(MAUDE)

MAUDE is used to support defensible premarket and postmarket device decisions.

Medical Devices

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.

Medical Devices

2 terms

PMA Supplement

PMA Supplement is used to support defensible premarket and postmarket device decisions.

Medical Devices

Premarket Approval(PMA)

The FDA process for approving Class III high-risk medical devices based on clinical evidence of safety and effectiveness.

Medical Devices

1 terms

Quality System Regulation(QSR)

FDA regulations governing the methods and facilities used in the manufacture of medical devices.

Medical Devices

1 terms

Software AS A Medical DEVICE

Software AS A Medical DEVICE is used to support defensible premarket and postmarket device decisions.

Medical Devices

1 terms

Unique Device Identification(UDI)

A system for identifying medical devices through their distribution and use using a unique numeric or alphanumeric code.

Medical Devices