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Sec.
820.1 Scope.
Link
to an amendment published at 69 FR 29829, May 25, 2004. (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 § 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. Interpretation:
The
applicability of Current good manufacturing practice (cGMP)are applicable to
all medical devices of class II or higher and Class I devices as listed in §
820.30(a)(2). This list
includes Devices automated with computer software. This
section indicates that the regulation does not apply to manufacturers of
components or parts of finished devices, ...but are “encouraged” to use
appropriate provisions. Note that a "Component"
is defined in 820.3(c) of the Quality System (QS) regulation as any material,
substance, piece, part, software, firmware, labeling, or assembly, which is
intended to be included in the finished, packaged, and labeled device. For
example, fasteners, blood tubing assemblies and labels are components. This
definition excludes "manufacturing materials," which by definition,
are not intended to be included as part of the finished, packaged, and
labeled device. (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. Interpretation:
It
doesn’t matter if you are making this product in the US or outside of the
US. If the intention is to sell
the product in America you will require following the Quality System
Regulation. (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. Interpretation:
This
is an important piece of information.
It implies correctly that the FDA are humans that are open to
discussion. The words “where appropriate” is may be frustrating for some who
fail to see the benefit of having something open for discussion. In fact if
you have any confusion as to whether or not a piece of legislation applies or
if you are having trouble with the interpretation of regulation, then contact
the FDA.
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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