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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B107. QUALITY SYSTEM REGULATION |
Section 22-B10799. DEFINITIONS
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10799.1 As used in this chapter, the following terms shall have the meanings ascribed:
Act – the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938 (21 U.S.C. § 301, et seq.)
Complaint - any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
Component - any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.
Control number - any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined.
Design history file (DHF) - a compilation of records which describes the design history of a finished device.
Design input – the physical and performance requirements of a device that are used as a basis for device design.
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 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 – establishing by objective evidence that device specifications conform to users’ needs and intended use(s).
Device history record (DHR) – a compilation of records containing the production history of a finished device.
Device master record (DMR) – a compilation of records containing the procedures and specifications for a finished device.
Establish – define, document (in writing or electronically), and implement.
Finished device – any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
Lot or batch – one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.
Management with executive responsibility – those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.
Manufacturer – any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.
Manufacturing material – any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.
Nonconformity – the non-fulfillment of a specified requirement.
Process validation – establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
Product – components, manufacturing materials, in-process devices, finished devices, and returned devices.
Quality – the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.
Quality audit – a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.
Quality policy - the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.
Quality system - the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.
Remanufacturer – any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.
Rework – action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.
Specification – any requirement with which a product, process, service, or other activity must conform.
Validation – confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
Verification – confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.