Regulatory Terms Starting With D

Data Integrity (DI)

The completeness, consistency, and accuracy of data throughout its lifecycle, following ALCOA+ principles.

DATA Monitoring Committee

DATA Monitoring Committee is central to trial design quality, protocol execution, and evidence credibility.

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.

Deficiency LETTER

Deficiency LETTER supports cross-functional regulatory execution across quality, clinical, and safety teams.

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.

Development SAFETY UPDATE REPORT

Development SAFETY UPDATE REPORT guides risk surveillance, reporting discipline, and benefit-risk decision updates.

Deviation

A departure from an approved procedure, specification, or established standard during manufacturing or testing.

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.

Disproportionality

Disproportionality helps teams standardize terminology and improve decision traceability.

Drug Master File (DMF)

A confidential document submitted to FDA containing detailed information about manufacturing facilities, processes, or components.

DRUG Product

DRUG Product helps teams standardize terminology and improve decision traceability.

DRUG Substance

DRUG Substance helps teams standardize terminology and improve decision traceability.