21 C.F.R. § 820.3

Current through March 31, 2024

Section 820.3 - [Effective 2/2/2026] Definitions

The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.

(a) The following terms, which are either not used or not defined in ISO 13485 or in Clause 3 of ISO 9000, also apply for the purposes of this part:

Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly that is intended to be included as part of the finished, packaged, and labeled device.

Federal Food, Drug, and Cosmetic Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., as amended.

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.

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) of this chapter and that is also regulated as a device.

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.

(b) All definitions in section 201 of the Federal Food, Drug, and Cosmetic Act shall apply to the regulation of quality management systems under this part and shall supersede the correlating terms and definitions in ISO 13485 (e.g., the definitions of device and labeling in section 201(h) and (m) of the Federal Food, Drug, and Cosmetic Act apply to this part and supersede the definitions for the correlating terms in ISO 13485 (labelling and medical device)). In addition, the following terms and definitions apply to this part and supersede the definitions for the correlating terms in ISO 13485 or ISO 9000:

Implantable medical device shall have the meaning of "implant" as defined in section 860.3 of this chapter.

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.

Organization shall have the meaning of "manufacturer" as defined in this part.

Rework means action taken on a nonconforming product so that it will fulfill the specified requirements in the medical device file (MDF) before it is released for distribution.

Safety and Performance shall have the meaning of "safety and effectiveness" in Clause 0.1 of ISO 13485. The phrase "safety and performance" does not relieve a manufacturer from any obligation to implement controls or other measures that provide reasonable assurance of safety and effectiveness.

21 C.F.R. §820.3

89 FR 7523, 2/2/2026