[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.1]

[Page 138-139]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 820--QUALITY SYSTEM REGULATION--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 820.1  Scope.


    (a) Applicability. (1) Current good manufacturing practice (CGMP) 
requirements are set forth in this quality system regulation. 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 ensure that 
finished devices will be safe and effective and otherwise in compliance 
with the Federal Food, Drug, and Cosmetic Act (the act). This part 
establishes basic requirements applicable to manufacturers of finished 
medical devices. 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. With respect to class I devices, 
design controls apply only to those devices listed in Sec. 820.30(a)(2). 
This regulation does not apply to manufacturers of components or parts 
of finished devices, but such manufacturers are encouraged to use 
appropriate provisions of this regulation as guidance. Manufacturers of 
human blood and blood components are not subject to this part, but are 
subject to part 606 of this chapter.

[[Page 139]]

    (2) The provisions of this part shall be applicable to any finished 
device as defined in this part, intended for human use, that is 
manufactured, imported, or offered for import in any State or Territory 
of the United States, the District of Columbia, or the Commonwealth of 
Puerto Rico.
    (3) In this regulation the term ``where appropriate'' is used 
several times. When a requirement is qualified by ``where appropriate,'' 
it is deemed to be ``appropriate'' unless the manufacturer can document 
justification otherwise. A requirement is ``appropriate'' if 
nonimplementation could reasonably be expected to result in the product 
not meeting its specified requirements or the manufacturer not being 
able to carry out any necessary corrective action.
    (b) Limitations. The quality system regulation in this part 
supplements regulations in other parts of this chapter except where 
explicitly stated otherwise. In the event that it is impossible to 
comply with all applicable regulations, both in this part and in other 
parts of this chapter, the regulations specifically applicable to the 
device in question shall supersede any other generally applicable 
requirements.
    (c) Authority. Part 820 is established and issued under authority of 
sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 
801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 
360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any 
applicable provision in this part renders a device adulterated under 
section 501(h) of the act. Such a device, as well as any person 
responsible for the failure to comply, is subject to regulatory action.
    (d) Foreign manufacturers. If a manufacturer who offers devices for 
import into the United States refuses to permit or allow the completion 
of a Food and Drug Administration (FDA) inspection of the foreign 
facility for the purpose of determining compliance with this part, it 
shall appear for purposes of section 801(a) of the act, that the methods 
used in, and the facilities and controls used for, the design, 
manufacture, packaging, labeling, storage, installation, or servicing of 
any devices produced at such facility that are offered for import into 
the United States do not conform to the requirements of section 520(f) 
of the act and this part and that the devices manufactured at that 
facility are adulterated under section 501(h) of the act.
    (e) Exemptions or variances. (1) Any person who wishes to petition 
for an exemption or variance from any device quality system requirement 
is subject to the requirements of section 520(f)(2) of the act. 
Petitions for an exemption or variance shall be submitted according to 
the procedures set forth in Sec. 10.30 of this chapter, the FDA's 
administrative procedures. Guidance is available from the Center for 
Devices and Radiological Health, Division of Small Manufacturers 
Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., 
telephone 1-800-638-2041 or 1-301-443-6597, FAX 301-443-8818.
    (2) FDA may initiate and grant a variance from any device quality 
system requirement when the agency determines that such variance is in 
the best interest of the public health. 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.

[61 FR 52654, Oct. 7, 1996, as amended at 65 FR 17136, Mar. 31, 2000; 65 
FR 66636, Nov. 7, 2000]