C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 820—QUALITY MANAGEMENT SYSTEM REGULATION › Subpart A—General Provisions

21 C.F.R. § 820.3

Definitions

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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:

Batch or lot 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.

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.

[89 FR 7523, Feb. 2, 2024; 89 FR 82945, Oct. 15, 2024]
Notes of Decisions
Cited in 13 cases (3 in the last 5 years), 1980–2025 · leading case: Walter Shuker v. Smith & Nephew PLC
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Walter Shuker v. Smith & Nephew PLC (2018) ca3 “" 21 C.F.R. § 820.3 (c). 10 Second , the Act's provision for off-label use supports a component-level analysis.”
Brian Howard v. Sulzer Orthopedics, Inc. (2010) ca6 · cites it 2× “See 21 C.F.R. § 820.3 (p). Howard argues that the presence of “hydrocarbon components that are normally associated with mineral oil” on his NK-II means that Sulzer failed to “ensure” that it had removed manufacturing material in compliance with § 820.”
Glennen v. Allergan, Inc. (2016) calctapp “” ( 21 C.F.R. § 820.3 (f) (2016).) Whatever else this regulatory language may mean, nothing suggests that it pertains to training programs for surgeons who implant medical devices.”
Oliver v. Johnson & Johnson, Inc. (1994) pawd “” 21 C.F.R. § 820.3 (f). “Critical devices are subject to additional regulations governing the control of device components, production controls, processing controls, device labeling, distribution, and recordkeeping.”
Anguiano v. E.I. Du Pont de Nemours & Co. (1995) ca9 “21 C.F.R. § 820.3 . That regulation, however, is expressly "not intended to apply to manufacturers of components or parts of finished devices.”
In Re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation (2009) gamd “” 21 C.F.R. § 820.3 (b). Once a manufacturer receives a “complaint,” it must be reviewed, evaluated, and documented.”
Cody v. ConforMIS, Inc. (2016) mad “See 21 C.F.R. §§ 820.3 (z), (aa) (defining “validation” and “verification”).”
United States v. Two Units, More or Less, of an Article or Device, Consisting of a Power Unit & a Chair (1995) ca9 “To the contrary, 21 C.F.R. § 820.3 (k) defines a manufacturer as “any person, including any repacker and/or rela-beler, who manufactures, fabricates, assembles, or processes a finished device.”
Dreger v. KLS Martin, LP (2023) ohsd · cites it 2× “§ 803 , it also is a manufacturer for purposes of 21 C.F.R. § 820.3 . This belief, however, is misplaced because the two sets of regulations have distinct definitions of “manufacturer.”
United States v. Utah Medical Products, Inc. (2005) utd · cites it 3× “Utah Medical also manufactures “components,” as defined at 21 C.F.R. § 820.3 (c) (2004), 1 because it manufactures parts or subassemblies that are intended to be included as part of finished, packaged, and labeled medical devices.”
<font color=\red\">DO NOT FILE IN THIS CASE</font>- TRANSFERRED TO CAMDEN - NEW CIVIL ACTION NO. 1:19-cv-15627" (2021) njd “” 21 C.F.R. § 820.3 (p) (emphasis added), Aside from Plaintiffs’ conclusory allegation that the shedded material was “residual debris,” (Am.”
Mallon v. Hologic CA6 (2025) calctapp “(See 21 C.F.R. § 820.3 (a).) “ISO 13485” refers to an international standard that specifies the requirements a medical device corporation must have for its quality management system.”
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— 21 C.F.R. § 820.3(c) — 1 case
United States v. Utah Medical Products, Inc. (2005) utd “Utah Medical also manufactures “components,” as defined at 21 C.F.R. § 820.3 (c) (2004), 1 because it manufactures parts or subassemblies that are intended to be included as part of finished, packaged, and labeled medical devices.”
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