IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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Page 15 of 43

REGULATIONS & STANDARDS Section 6.0, Scientifi c Validity Determination, discusses when it is necessary to determine scientifi c validity, the potential sources upon which to base scientifi c validity, and important principles in the appraisal and analysis of scien- tifi c validity information. Performance Evaluation Section 7.0, Performance Evaluation, of the proposed document on scientifi c validity determination and perfor- mance evaluation, places IVD medical devices into three categories: established and standardized tests, established and nonstandardized tests, and novel tests, referring to these categories when providing guidance on the type of analytical performance data, and, where appropriate, clinical perfor- mance data that should be generated. Section 7.1, Analytical Performance, explains that analytical performance, namely technical test performance, generally using human speci- mens, is always expected for IVD medical devices. Th e doc- ument states that analytical performance data may include data to demonstrate accuracy (in terms of trueness and pre- cision), analytical sensitivity, analytical specifi city, linearity, limit of detection and limit of quantitation, cut-off , measur- ing range, carry-over, determination of appropriate speci- men collection and handling, and endogenous interference on assay results. Th e guidance provided in Section 7.2, Clinical Per- formance, is analogous to guidance on clinical evaluation as part of the European CE marking process and GHTF guidance applicable to medical devices other than IVD medical devices.2, 3 mance data can be derived from clinical performance stud- ies, literature, and experience gained by routine diagnostic testing. Each of these data sources is discussed in this section; however, a separate guidance document has been developed for clinical performance studies and is discussed next. Once clinical performance data have been identifi ed, the data must be appraised to determine the relevance and quality to address questions about the IVD medical device and the data's contribution to demonstrating the device's clinical performance. A clinical performance analysis col- lectively evaluates all appraised information in terms of weight and signifi cance. Th e potential sources of clinical perfor- Clinical Performance Studies Th e proposed document, Clinical Performance Studies for In Vitro Diagnostic Medical Devices, dated January 26, 2012, can be obtained from the GHTF website at www. ghtf.org/sg5/sg5-proposed.html. It begins by stating that the purpose of a clinical performance study is to validate aspects of IVD medical device performance that cannot be determined by analytical testing, literature, or previous expe- rience gained by routine diagnostic testing. A discussion of all sections of the document is beyond the scope of this article; however, three are discussed below. Section 6, Clinical Performance Study Design Type, 16 IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 discusses the types of clinical performance study designs as observational or interventional. An observational study refers to a study in which test results are not used for patient management and do not impact treatment decisions. Interventional studies are those in which test results may infl uence patient management decisions and may be used to guide treatment. Readers should refer to the proposed document for a full description of these types of designs. Th e proposed document also lists several practical examples of each type. Section 7, Clinical Performance Study Design Consid- erations, discusses the eff ect that the test purpose, such as diagnosis, screening, or monitoring, will have on the study design, such as sample size. Th is section also discusses the use of diff erent types of samples in clinical performance studies, including purposefully collected, leftover, and archived specimens. Other parts of this section provide guidance regarding site location, statistical design, potential risks, and ethical considerations, including informed consent and ethics committee involvement. Section 8, Clinical Performance Study Protocol, provides a useful list of important information that should be pro- vided regarding study design such as: purpose, objectives, study population, description of test method(s) and inter- pretation of results, site training and monitoring, specimen type, specimen collection, preparation, handling and stor- age, inclusion and exclusion criteria, limitations, warnings and precautions, data collection/management, data analysis, required materials, and number of study sites. Word of Caution Th e content of the GHTF IVD medical device proposed documents discussed in this article could change before pub- lication as fi nal documents. Nonetheless, even as proposed documents, they provide useful interpretations concerning important principles and concepts on IVD performance evaluation data. Manufacturers using these proposed docu- ments, and eventually their fi nal versions, in their eff orts to meet specifi c country and regional regulatory requirements will need, however, always to base their actions on the laws and regulations in those regions or countries, as well as on relevant standards and guidance documents, and the results of any consultations with offi cial bodies and regulatory authorities. References 1. Center for Devices and Radiological Health, FDA, Guidance for Industry - Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review (20 May 1998), www.fda.gov/MedicalDevices/Device- RegulationandGuidance/GuidanceDocuments/ucm080183.htm 2. Global Harmonisation Task Force, Clinical Evaluation (May 2007), www. ghtf.org/sg5/sg5-fi nal.html 3. Clinical Evaluation: A Guide for Manufacturers and Notifi ed Bodies (MED- DEV 2.7.1 Rev.3, December 2009); http://ec.europa.eu/enterprise/sectors/ medical-devices/fi les/meddev/2_7_1rev_3_en.pdf IVD ivdtechnology.com

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