The Good Manufacturing Practices (GMP) regulation, promulgated under
section 520 of the Food,
Drug and Cosmetic Act, requires that domestic or foreign manufacturers
of medical devices intend for commercial distribution in the United
States have a quality assurance (QA) program. The regulation requires
that various specifications and controls be established for devices
and that finished devices meet these specifications. Thus, the GMP
regulation helps assure that medical devices are safe and effective
for the intended use. The Food and Drug Administration (FDA) monitor
device compliance with the QA program requirements in the regulation.
Manufactures and importers of medical devices must also comply with
the Medical Device Reporting (MDR) regulation, 21 CFR Part 803,
which requires that serious complaints be reported to the FDA.
The GMP regulations apply to the manufacture of finished devices
intended to be commercially
distributed for human use unless there is an approved exemption
Certain components such as blood tubing and major diagnostic x-ray
components may be considered to be finished devices because they
are accessories to finished devices. The manufacturer of such components
or accessories is subject to the GMP regulation when the accessory
device is labeled and sold separately from the primary device for
a health-related purpose to a hospital, physician, or other user.
The designation of a device as a "custom" device does
not confer a GMP exemption.
Contract manufacturers and specification developers must comply
with the sections of the GMP regulation that apply to the functions
they perform. Contract test laboratories are considered an extension
of a manufacturer's quality assurance program and presently are
not routinely scheduled for GMP inspections.
Internal test laboratories, however, that are part of a corporate
firm that provides services to individual corporation factories,
are inspected as part of the FDA GMP inspection of the member factories.
Device Good Manufacturing Practices Manual fourth Edition