IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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Vitro Diagnostic Medical Devices Directive (IVDD; 98/79/ EC). Th at is, the conformity assessment procedures of the IVDD, which specifi es that performance evaluation "data should originate from studies in a clinical or other appropri- ate environment or result from relevant biographical refer- ences." Th e new proposal for a European IVD regulation is even more closely aligned with the GHTF approach. In addition, GHTF concepts are consistent with the process of evaluating clinical data for establishing or supporting safety and eff ectiveness of an IVD medical device for U.S. clear- ance or approval; however, it will be necessary to comply fi rst and foremost with all applicable U.S. laws and regula- tions and, where appropriate, follow relevant FDA guidance documents. It is also useful to note that FDA has stated that the principles outlined in an agency guidance document on the use of published literature for supporting Premarket Approval (PMA) supplements may be applicable to 510(k), PMA, and Humanitarian Device Exemption submissions.1 Scientifi c Validity and Performance Evaluation Th e proposed document, Clinical Evidence for IVD Medical Devices - Scientifi c Validity Determination and Performance Evaluation, dated September 16, 2011, can be obtained from the GHTF website at www.ghtf.org/sg5/sg5- proposed.html. Th e purpose of the document is to provide guidance on how to collect and document clinical evidence for an IVD medical device as part of the conformity assess- ment procedure before placing the device on the market, as well as to support its ongoing marketing. It is also intended to provide guidance to regulators and others when assessing clinical evidence provided by manufacturers. Th e principal areas covered in this document are: defi - nitions, general principles of clinical evidence, scientifi c validity determination, performance evaluation (including analytical performance and clinical performance), and clini- cal evidence report. Appendix A provides a possible format for a literature search report. Appendix B includes a fl ow chart illustrating possible methodology for documenting, screening, and selecting literature within a literature search report. Th e defi nitions provided in the document, such as "diagnostic sensitivity," "diagnostic specifi city," "examina- tion," and others are consistent with the European harmo- nized standard, EN ISO 18113-1:2011, In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, defi nitions and general require- ments (ISO 18113-1:2009). Section 5.0, General Principles of Clinical Evidence, provides useful concepts regarding clinical evidence and its importance as well as information on methods for generating and documenting clinical evidence for an IVD medical device. Miniature Solenoid Valve X-Valve Miniature Air Diaphragm Pump - CTS Miniature Inert Valve - Series 3 Miniature Proportional Valve - VSO Liquid Isolation Valve LQX Miniature Air Diaphragm Pump T2-05 For precise flow control of gases and liquids, Parker's miniature valves and pumps are ideally suited for medical instrumentation, anesthesia delivery, respiratory therapy, patient therapy and clinical diagnostics. From the laboratory to the operating room to home health care, Parker's innovative solutions are designed to help improve health care. With our application engineered pneumatic and liquid control valves and miniature diaphragm pumps, Parker Precision Fluidics Division is your fluidic systems expert. www.parker.com/precisionfluidics/markets ivdtechnology.com IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 15

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