- Act
-
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. [From §820.3(a)]
- Batch
-
See Lot
- 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. [From §820.3(b)]
- 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. [From
§820.3(c)]
- 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. [From
§820.3(d)]
- Design History File (DHF)
-
A compilation of records which describes the design history of a finished
device. [From §820.3(e)]
- Design Input
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The physical and performance requirements of a device that are used as a
basis for device design. [From §820.3(f)]
- 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. [From §820.3(g)]
- 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. [From
§820.3(h)]
- Device History Record (DHR)
-
A compilation of records containing the production history of a finished
device. [From §820.3(i)]
- Device Master Record (DMR)
-
A compilation of records containing the procedures and specifications for a
finished device. [From §820.3(j)]
- Establish
-
Define, document (in writing or electronically), and implement. [From
§820.3(k)]
- 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. [From §820.3(l)]
- 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. [From §820.3(m)]
- 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. [From
§820.3(n)]
- 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. [From
§820.3(o)]
- 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. [From
§820.3(p)]
- Nonconformity
-
The nonfulfillment of a specified requirement. [From §820.3(q)]
- Product
-
Components, manufacturing materials, in- process devices, finished devices,
and returned devices. [From §820.3(r)]
- Quality
-
The totality of features and characteristics that bear on the ability of a device
to satisfy fitness-for-use, including safety and performance. [From §820.3(s)]
- 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. [From §820.3(t)]
- Quality Policy
-
The overall intentions and direction of an organization with respect to quality,
as established by management with executive responsibility. [From §820.3(u)]
- Quality System
-
The organizational structure, responsibilities, procedures, processes, and
resources for implementing quality management. [From §820.3(v)]
- 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. [From
§820.3(w)]
- Rework
-
Action taken on a nonconforming product so that it will fulfill the specified
DMR requirements before it is released for distribution. [From §820.3(x)]
- Specification
-
Any requirement with which a product, process, service, or other activity
must conform. [From §820.3(y)]
- Validation
- 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). [From
§820.3(z)]
-
Verification
-
Confirmation by examination and provision of objective evidence that
specified requirements have been fulfilled. [From §820.3(aa)]
