Resources

• Summative human factors study

  The summative usability evaluation is the final validation intended to demonstrate that all risks have been identified and adequately addressed, and that the impact of residual risks is minimized or acceptable. The summative phase can begin after any final changes are made to the design and a production ready model of the device has been produced. It is expected that the study protocol will closely follow the format of those conducted during the final formative evaluation.

• Formative human factors studies

  Evaluations for deriving information from user interaction with devices under conditions of varying degrees of formality and may include various simulated-use testing approaches. Formative studies that involve use of the device by representative end users are useful for identifying problems that were not identified or sufficiently understood using analytical methods, early in the design process when they can be addressed more easily and less expensively.

• Critical material attributes

  (CMAs) that are independent of CQAs and provide specific goals with which to evaluate a manufacturing process. Provide a mechanistic link of the product quality to the manufacturing process.

• Critical quality attributes

  A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. CQAs are generally associated with the drug substance, excipients, intermediates , and drug product.

• Design transfer

  Requirement that each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

• Design review

  A documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.

• Design validation

  Establish by objective evidence that device specifications conform with user needs and intended use(s).

• Design verification

  Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

• Design history file

  A compilation of records which describes the design history of a finished device. DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

• Design output

  The results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.

• Design input

  The physical and performance requirements of a device that are used as a basis for device design.

• PQ/LR

  Decision to File

• DTF

  Decision to File

• EP2

  End of Phase 2

• EP1

  End of Phase 1

• PCD

  Preclinical Candidate Development

• PCD

  Preclinical Candidate Development

• LCS

  Lead Chemical Series Selection

• PoC

  Proof of Concept

• IPDP

  Integrated Project Development Plan

• PDWF

  Product Development Work Flow

• URS

  User Requirements Specification

• COGS

  Cost of Goods Sold

• FIH

  First in Human Study

• NDA

  Non-Disclosure Agreement

• IND

  Investigational New Drug

• CMC

  Chemistry, Manufacturing & Controls