Design Control Guidance For Medical Device Manufacturers教程.pdf
Center for Devices and Radiological Health DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS This Guidance relates to FDA 21 CFR and Sub-clause of ISO 9001 March 11, 1997 FOREWORD 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 ponent 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 ply 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 plements 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 Draft guidance was made publicly available in March, 1996.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 ments, suggestions for improvement, and encouragement we received from industry, interested parties, and the Global Harmonization Task Force (GHTF) Study Group 3. ments were systematically reviewed, and revisions made in response to ments 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 als
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