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FDA Approved Good Manufacturing Procedures |
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| BioMeridian operates with strict adherence to the good
manufacturing procedures set for by the FDA. Those procedures known as
"Design Control Guidance for Medical Device Manufacturers" can be found on
the FDA's official website at http://www.fda.gov/cdrh/comp/designgd.html .
The following the foreword is listed there as an introduction to these
guidelines. |
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To ensure that good quality assurance practices are used
for the design of medical devices and that they are consistent with quality
system requirements worldwide, the Food and Drug Administration revised the
Current Good Manufacturing Practice (CGMP) requirements by incorporating
them into the Quality System Regulation, 21 CFR Part 820. An important
component of the revision is the addition of design controls.
Because design controls must apply to a wide variety of devices, the
regulation does not prescribe the practices that must be used. Instead, it
establishes a framework that manufacturers must use when developing and
implementing design controls. The framework provides manufacturers with the
flexibility needed to develop design controls that both comply with the
regulation and are most appropriate for their own design and development
processes.
This guidance is intended to assist manufacturers in understanding the
intent of the regulation. Design controls are based upon quality assurance
and engineering principles. This guidance complements the regulation by
describing its intent from a technical perspective using practical terms and
examples.
Draft guidance was made publicly available in March, 1996. We appreciate the
many comments, suggestions for improvement, and encouragement we received
from industry, interested parties, and the Global Harmonization Task Force (GHTF)
Study Group 3. The comments were systematically reviewed, and revisions made
in response to those comments and suggestions are incorporated in this
version. As experience is gained with the guidance, FDA will consider the
need for additional revisions within the next six to eighteen months.
The Center publishes the results of its work in scientific journals and in
its own technical reports. Through these reports, CDRH also provides
assistance to industry and to the medical and healthcare professional
communities in complying with the laws and regulations mandated by Congress.
These reports are sold by the Government Printing Office (GPO) and by the
National Technical Information Service (NTIS). Many reports, including this
guidance document, are also available via Internet on the World Wide Web at
www.fda.gov.
We welcome your comments and suggestions for future revisions. |
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/signed/
D. Bruce Burlington, M.D.
Director
Center for Devices and Radiological Health |
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Request More Information Now |
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| Study Groups NEW |
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BioMeridian study groups are informal events, hosted by a BioMeridian representative,
designed to ensure access to local, hands-on support, for our customers after they have
received basic training. The study groups are held regularly throughout the country to
ensure each of our customers has the chance to receive continued support and the opportunity
to meet other practitioners in the field. These events are for practitioners (or staff)
only and are not appropriate for the general public or patients.
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| COMING SOON |
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BioMeridian International |
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