Regulatory Terms Starting With D

9 terms in the D index.

• Data Integrity (DI)

  Data integrity is the property of regulated records being complete, consistent, and accurate across their full lifecycle, from first capture through retention, so a reviewer can reconstruct an activity without relying on the people who performed it.

• Data Monitoring Committee (DMC)

  A Data Monitoring Committee is an independent group of clinicians and statisticians that reviews unblinded accumulating data during a trial and recommends to the sponsor whether to continue, modify, or terminate it.

• De Novo Classification Request (De Novo)

  De Novo Classification Request is an FDA premarket submission that asks the agency to classify a novel device into class I or class II when no legally marketed device exists to support a 510(k) substantial equivalence review.

• Decentralized Clinical Trial (DCT)

  Decentralized Clinical Trials are clinical investigations in which some or all participant activities, including consent, dosing, assessments and safety monitoring, happen at the participant's home or a local provider instead of the investigator's research site.

• Design Controls

  Design controls are the FDA-mandated design and development requirements for medical devices, governing how a device is planned, specified, verified, validated, and transferred to production, unlike production controls that govern manufacture of an already-approved design.

• Design Space (Design Space)

  Design Space is the regulator-approved multivariate region of input material attributes and process parameters demonstrated to assure quality, inside which a manufacturer can move without filing a post-approval change.

• Deviation

  Deviation is a departure from an approved instruction, procedure, specification, or established standard in a regulated process, which GMP requires to be recorded and justified, and investigated whenever it is critical or unexplained.

• DMF (Drug Master File)

  A DMF is a standalone submission of confidential manufacturing, packaging, or excipient information that FDA reviews only when an application incorporates it by reference, letting a supplier support a customer's filing without disclosing trade secrets.

• DSUR (Development Safety Update Report)

  DSUR is the annual clinical-trial safety report a sponsor submits to regulators for an investigational drug, consolidating all trials of that drug worldwide, unlike the PSUR, which covers products already on the market.