FDA Approved
FDA Approved Good Manufacturing Procedures
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.
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Draft guidance was made publicly available in March, 1996.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.
/signed/
D. Bruce Burlington, M.D.
Director
Center for Devices and Radiological Health