IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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REGULATIONS & STANDARDS Proposed Guidance on IVD Clinical Evidence and Performance Evaluation Manufacturers of IVD devices should be aware of three proposed Global Harmonization Task Force guidance documents on clinical evidence for IVD devices. Th e documents cover defi nitions and terminology, determining scientifi c validity, performance evaluation, and clinical performance studies. The Global Harmonization Task Force (GHTF; www.ghtf.org), created in 1992 in an eff ort to promote the international harmonization of medical device regulation, is a voluntary group of representatives from national medi- cal device regulatory authorities and the regulated indus- try. GHTF develops guidance documents that provide a model for the regulation of medical devices that can then be adopted by regulatory authorities. Th e model, which is based on a set of Essential Principles of Safety and Perfor- mance, is closely aligned with the European medical device regulatory framework. Th e GHTF soon will be replaced by the International Medical Device Regulators Forum (IMDRF; www.imdrf. org), created in February 2011 to discuss future directions in medical device regulatory harmonization. In contrast to the GHTF, membership is limited to representatives from medical device regulatory authorities; however, IMDRF may permit nonregulator stakeholders to join working groups. Fortunately, IMDRF has indicated that it will develop a for- mal strategy for the management and maintenance of GHTF documents. Th e adoption of the documents discussed in this article, expected to occur in late October 2012, and their sub- sequent publication, will be managed by GHTF; however, future revisions will be managed by IMDRF. Guidance on Key Defi nitions and Concepts Th e proposed document, Clinical Evidence for IVD Medical Devices–Key Defi nitions and Concepts, dated Sep- tember 16, 2011, can be obtained from the GHTF website at www.ghtf.org/sg5/sg5-proposed.html. As with all three proposed documents discussed here, the contents could change as a result of comments received or further delibera- tions during development of the fi nal document. 14 IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 Th e proposed document provides defi nitions and expla- nations for the following terms: • scientifi c validity of an analyte (measurand); clinical evidence of an IVD medical device; • performance of an IVD medical device, including analyti- • cal performance and clinical performance; performance evaluation of an IVD medical device; • clinical utility of the IVD medical device; • intended use/purpose. • In addition, it attempts to illustrate, with a fi gure con- sisting of two overlapping circles, that scientifi c validity and clinical performance are common elements of clinical evi- dence and clinical utility. For example, "clinical evidence of an IVD medical device" is defi ned as "all the information that supports the scientifi c validity and performance for its use as intended by the manufacturer." Th e term "performance evaluation of an IVD medical device" is defi ned as the "assessment and analysis of data to establish or verify the performance of an IVD medical device." Th e proposed document also explains that performance evaluation data "are typically generated from verifi cation and validation studies (including, where appropriate, clinical performance studies using human speci- mens) or obtained from a literature review that confi rms the performance characteristics of the product." Th ese defi ni- tions are consistent with the requirements specifi ed in the In Maria E. Donawa is a physician, pathologist, and pharmacist with more than 30 years' regulatory experience. She can be reached at medonawa@ donawa.com. ivdtechnology.com IMAGE BY MODELLA/SHUTTERSTOCK.COM

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