(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394)). All definitions in section 201 of the act shall apply to the regulations in this part.

(b) Complaint means 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.

(c) Component means 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.

(d) Control number means 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.

(e) Design history file

(DHF) means a compilation of records which describes the design history of a finished device.

(f) Design input means the physical and performance requirements of a device that are used as a basis for device design.

(g) Design output means 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.

(h) Design review means 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.

(i) Device history record

(DHR) means a compilation of records containing the production history of a finished device.

(j) Device master record

(DMR) means a compilation of records containing the procedures and specifications for a finished device.

(k) Establish means define, document (in writing or electronically), and implement.

(l) Finished device means 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.

(m) Lot or batch means 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.

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

(o) Manufacturer means 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.

(p) Manufacturing material means 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.

(q) Nonconformity means the nonfulfillment of a specified requirement.

(r) Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.

(s) Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.

(t) Quality audit means 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.

(u) Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.

(v) Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

(w) Remanufacturer means 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.

(x) Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.

(y) Specification means any requirement with which a product, process, service, or other activity must conform.

(z) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

(1) Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

(2) Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

(aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

(bb) Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in §1271.3(d) of this chapter that does not meet the criteria in §1271.10(a) and that is also regulated as a device.

(cc) Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of §830.20 of this chapter. A unique device identifier is composed of:

(1) A device identifier—a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and

(2) A production identifier—a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:

(i) The lot or batch within which a device was manufactured;

(ii) The serial number of a specific device;

(iii) The expiration date of a specific device;

(iv) The date a specific device was manufactured.

(v) For an HCT/P regulated as a device, the distinct identification code required by §1271.290(c) of this chapter.

(dd) Universal product code (UPC) means the product identifier used to identify an item sold at retail in the United States.

[61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013]