欧盟指导原则 Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology.docxVIP

Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology DRAFT DOCUMENT This guidance document is being distributed for comment purposes only. Clinical Chemistry and Toxicology Devices Branch Division of Clinical Laboratory Devices Office of Device Evaluation Draft released for comment on 2/28/97 Comments and suggestions regarding this draft document should be submitted within 60 days of the above release date to: Joseph Hackett, Ph.D., Associate Director, Division of Clinical Laboratory Devices, 10903 New Hampshire Avenue, Silver Spring, MD 20993. ?Comments and suggestions received after this may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the draft document, contact the Division of Clinical Laboratory Devices via phone 301-796-0695. U. S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Devices and Radiological Health REVIEW CRITERIA FOR ASSESSMENT OF PORTABLE BLOOD GLUCOSEMONITORING IN VITRO DIAGNOSTIC DEVICES USING GLUCOSE OXIDASE,DEHYDROGENASE, OR HEXOKINASE METHODOLOGY VERSION 02/14/96 This is a flexible document presenting current guidance on the preparation of premarket notifications (510(k)s) for glucose in vitro diagnostics devices employing enzymatic methodologies. It is based on l) current technology, 2) clinical experience, 3) previous submissions by manufacturers to the Food and Drug Administration (FDA), and 4) Safe Medical Devices Act of 1990 and regulations in the Code of Federal Regulations (CFR). So that we may revise the draft as necessary, please send your comments to the address given below. Division of Clinical Laboratory Devices 10903 New Hampshire Avenue Silver Spring, MD 20993 ? DEFINITION: Portable blood glucose devices are intended for use in hospitals, at point of care, in physicians offices, and over-the-counter as in vitro diag