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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.
(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.
Rev
2006-11-18 12:03:32 -0700
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