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. § 820.1

Scope

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(a) Applicability. Current good manufacturing practice (CGMP) requirements are set forth in this quality management system regulation (QMSR). The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to assure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act and that the use of other terminology, such as “safety and performance,” in this part does not change this statutory standard or the requirements of this part. Any manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation, or servicing of a finished device must establish and maintain a quality management system that is appropriate for its specific device(s). Manufacturers subject to this part include, but are not limited to, manufacturers that perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, as well as initial distributors of foreign entities that perform these functions. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.

(1) Finished devices. The provisions of this part shall apply to any finished device, as defined in this part, intended for human use, that is manufactured in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico, or that is imported or offered for import into the United States.

(2) Components or parts. The provisions of this part do not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to consider provisions of this regulation as appropriate.

(3) Blood and blood components. The provisions of this part do not apply to manufacturers of blood and blood components used for transfusion or for further manufacturing. Such manufacturers are subject to subchapter F of this chapter.

(4) HCT/Ps. The provisions of this part apply to manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in § 1271.3(d) of this chapter, that are devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions of the Federal Food, Drug, and Cosmetic Act or under a biological product license application under section 351 of the Public Health Service Act). HCT/Ps regulated as devices are also subject to the donor-eligibility requirements set forth in part 1271, subpart C of this chapter and applicable current good tissue practice requirements in part 1271, subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general regulation.

(b) Conflicts with other requirements under the Federal Food, Drug, and Cosmetic Act. The QMSR for devices in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. To the extent that any applicable requirements in this part conflict with requirements in other parts of this chapter, the requirements specifically applicable to the device in question shall supersede the more generally applicable requirements. Moreover, to the extent that any clauses of ISO 13485 (incorporated by reference, see § 820.7) conflict with any provisions of the Federal Food, Drug, and Cosmetic Act and/or its other implementing regulations, the Federal Food, Drug, and Cosmetic Act and/or its other implementing regulations will control.

(c) Foreign manufacturers. A device that is imported or offered for import into the United States is subject to refusal of admission to the United States under section 801(a) of the Federal Food, Drug, and Cosmetic Act if, among other things, it appears to be adulterated as set forth in the Federal Food, Drug, and Cosmetic Act and its implementing regulations.

(d) Exemptions or variances. (1) A manufacturer subject to any requirement under section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act, including any requirements under this part, may petition for an exemption or variance from such requirement in accordance with section 520(f)(2) of the Federal Food, Drug, and Cosmetic Act. Petitions for an exemption or variance shall be submitted in accordance with the procedures set forth in § 10.30 of this chapter.

(2) FDA may initiate and grant a variance from any requirement(s) in this part when the Agency determines that such variance is in the best interest of the public health, including that there is a public health need for the device and the device would not likely be made sufficiently available without the variance. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.

Notes of Decisions
Cited in 59 cases (11 in the last 5 years), 1989–2026 · leading case: Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010).
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Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010). · cites it 3× “21 C.F.R. § 820.1 (a)(1). (Many writers refer to these as QSRs and CGMPs.”
Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. 2011). · cites it 4× “” 21 C.F.R. § 820.1 (a)(1). To comply with the CGMP requirements, a device manufacturer must adopt a variety of procedures and controls relating to areas such as: (1) design control, (2) quality assurance, (3) manufacturing and processing, (4) process validation, (5) device…”
Kubicki ex rel. Kubicki v. Medtronic, Inc., 293 F. Supp. 3d 129 (D.C. Cir. 2018). · cites it 3× “, the generic FDA regulations that "govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use[,]" 21 C.F.R. § 820.1 (a)(1) -and also the…”
Glennen v. Allergan, Inc., 247 Cal. App. 4th 1 (Cal. Ct. App. 2016). · cites it 4× “) Such devices need not adhere to device-specific regulations because general quality controls, applicable to “all finished devices intended for human use” ( 21 C.F.R. § 820.1 (a) (2016)) are “sufficient to provide reasonable assurance of the safety and effectiveness of the…”
Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012). · cites it 2× “This Internet address redirects to FDA, Device Advice: Comprehensive Regulatory Assistance, http://www.fda.”
Raab v. Smith & Nephew, Inc., 150 F. Supp. 3d 671 (S.D.W. Va 2015). · cites it 4× “intended for human use,” 21 C.F.R. § 820.1 , are “sufficient to provide reasonable assurance of the safety and effectiveness of the device,” 21 U.”
In Re Abbott Labs. Derivative Shareholders Litig., 325 F.3d 795 (7th Cir. 2003). “§ 820 , and the requirements of the “Current Good Manufacturing Practice” (“CGMP”), as defined in 21 C.F.R. § 820.1 . These regulations expressly assign corporate management the responsibility to assure compliance with the CGMP.”
In Re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147 (D. Minnesota 2009). “” 21 C.F.R. § 820.1 (a)(1). But they are simply too generic, standing alone, to serve as the basis for Plaintiffs’ manufacturing-defect claims.”
United States v. 789 Cases, More or Less, 799 F. Supp. 1275 (D.P.R. 1992). · cites it 4× “21 C.F.R. § 820.1 (c); Twardochleb Testimony, day 4, p.”
Horowitz v. Stryker Corp., 613 F. Supp. 2d 271 (E.D.N.Y 2009). “” 21 C.F.R. § 820.1 (a)(1). However, the FDA recognizes that these requirements “are intended to serve only as ‘an umbrella quality system,’ providing ‘general objectives’ medical-device manufacturers must seek to achieve.”
Babayev v. Medtronic, Inc., 228 F. Supp. 3d 192 (E.D.N.Y 2017). · cites it 3× “The Eleventh Circuit had opined that *211 these claims would interfere with the consistent application of general federal regulations governing the labeling and manufacture of all medical devices, including the “Good Manufacturing Practices” set forth in 21 C.F.R. § 820.1 et…”
Medinol Ltd. v. Boston Sci. Corp., 346 F. Supp. 2d 575 (S.D.N.Y. 2004). “” 21 C.F.R. § 820.1 (a)(1). Thus, if the stent was a finished device, then Medinol, its manufacturer, would be subject to the requirements of the QSR, *602 including FDA inspection.”
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— 21 C.F.R. § 820.1(a)(1) — 3 cases
Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. 2011). “” 21 C.F.R. § 820.1 (a)(1). To comply with the CGMP requirements, a device manufacturer must adopt a variety of procedures and controls relating to areas such as: (1) design control, (2) quality assurance, (3) manufacturing and processing, (4) process validation, (5) device…”
Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012). “This Internet address redirects to FDA, Device Advice: Comprehensive Regulatory Assistance, http://www.fda.”
Kubicki v. Medtronic, Inc. (D.D.C. 2018).
— 21 C.F.R. § 820.1(c) — 1 case
Reynolds v. Medtronic, Inc. (S.D. Ohio 2021).
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