Validation
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.