Regulatory Terms Starting With D

Data Integrity (DI)

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

Data Monitoring Committee (DMC)

An independent group of experts that periodically reviews accumulating clinical trial data to monitor participant safety and trial integrity.

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.

Decentralized Clinical Trial (DCT)

A clinical trial where some or all trial activities take place at locations other than traditional research sites, often including patient homes.

Design Controls

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

Design Space (Design Space)

The multidimensional combination of input variables and process parameters demonstrated to provide assurance of quality, enabling operational flexibility within the defined region.

Development Safety Update Report (DSUR)

An annual comprehensive safety report submitted by sponsors of investigational drugs to regulatory authorities summarizing the safety profile during the reporting period.

Deviation

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

Drug Master File (DMF)

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