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Guidance for Industry and FDA Staff: in Vitro Diagnostic (IVD) Device Studies

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Guidance for Industry and FDA Staff: in Vitro Diagnostic (IVD) Device Studies 1 Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions Document issued on: June 25, 2010 The draft of this document was issued on October 25, 2007. This document supersedes "Guidance for FDA Staff: Regulating In Vitro Diagnostic Device (IVD) Studies," issued December 17, 1999. For questions regarding this document, contact Sally Hojvat, Ph.D. in CDRH at 301-796-5455 or the Office of Communication, Outreach and Development in CBER at 1-800-835-4709 or 301- 827-1800. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research 2 Preface Additional Copies Additional copies are available from the Internet at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu ments/ucm071230.pdf, Or, contact: Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448 Internet: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/defaul t.htm Tel: 800-835-4709 or 301-827-1800 3 Table of Contents I. Background................................................................................................................................4 II. Introduction.............................................................................................................................. 5 III. General Regulatory Issues..................................................................................................... 7 IV. Investigational Studies ......................................................................................................... 18 V. Human Subject Protection .................................................................................................... 22 VI. Data Considerations ............................................................................................................. 25 VII. Glossary ............................................................................................................................... 28 VIII. References .......................................................................................................................... 35 Appendix 1: REGULATORY DECISION TREE (21 CFR PART 812) for IVD INVESTIGATIONAL STUDIES .............................................................................................. 39 Appendix 2: Regulatory Framework for IVD Products ............................................................. Regulated as Class I, II, or III Devices...................................................................................... 42 Appendix 3: Sponsor’s Responsibilities for Significant Risk Device Investigations............. 42 Appendix 4: Investigator’s Responsibilities for Significant Risk Device Investigations...... 49 Appendix 5: Suggested Format for IDE Final Report ............................................................ 53 4 Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies Frequently Asked Questions This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. Background The Investigational Device Exemptions (IDE) regulation, Title 21, Code of Federal Regulations (21 CFR) Part 812, sets forth regulatory requirements for studies of investigational devices. Certain investigational IVD device studies (see the Glossary), however, are exempt from most of the provisions of 21 CFR Part 812 (21 CFR 1 812.2(c)(3)). This guidance document, written in question and answer format, is 2 intended to assist you (the manufacturer, sponsor, applicant, investigator and the IVD device industry in general) in the development of IVD studies, particularly those exempt from most of the requirements of the IDE regulation and to provide you with a broad view of the regulatory framework pertaining to the development phase of IVD devices. The information in this guidance document is also pertinent to investigators who participate in IVD studies and to institutional review boards (IRB) that review and approve such studies. The document is intended to facilitate the movement of new IVD technology from the investigational stage to the marketing stage. 1 As explained below, even if a particular IVD study is exempt from most requirements of 21 CFR Part 812, studies that will support applications to FDA are subject to 21 CFR 812.119 (Disqualification of a Clinical Investigator), 21 CFR Part 50 (Informed Consent), and 21 CFR Part 56 (Institutional Review Boards). 2 For the purpose of this document, “you” refers to the manufacturer, sponsor, applicant, investigator and the IVD device industry in general. If the text refers only to one or some of these entities, the appropriate entity is referenced by its name. 5 This guidance document outlines FDA regulations applicable to studies for investigational IVD devices, including those regulations related to human subject protection. The guidance also explains data considerations that ultimately will affect the quality of the premarket submission. This document includes a glossary, a reference list with related web addresses, and a quick-reference table. The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) each have regulatory responsibilities for IVD devices; information included in this document applies to Class I, II, and III IVD devices regulated by either Center. Note: Some devices used to test blood donor suitability, and blood donor and recipient compatibility are licensed as biological products under Section 351 of the Public Health Service Act and are subject to the applicable regulations in 21 CFR Parts 600-680 . Examples of licensed biologics devices include blood donor screening tests for human immunodeficiency virus (HIV) and hepatitis B and C tests intended for blood screening and reagents used in blood grouping, antibody detection and identification, and crossmatching for pre-transfusion compatibility testing. This guidance is written to address only IVD devices that are approved or cleared under the Federal Food, Drug, and Cosmetic Act (the Act) and Part 800 of the device regulations, regardless of which Center reviews the submission. If you have questions about a device licensed by CBER, you may go to the CBER website for published guidance (http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInf ormation/default.htm) or contact CBER for further information on applicable guidance and regulations. (See Introduction, Section II, question # 4, of this guidance for a listing of CBER contact numbers). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Introduction 1. What is the purpose of this guidance document and how does it differ from other guidance documents related to IVD products? FDA prepared this comprehensive document as a resource for you and for its own staff to address issues concerning IVD studies. This guidance document contains information relevant to studies conducted during the development of a new IVD product, as well as other general considerations about applicable requirements and marketing of the new device. It addresses particularly those investigational studies that are exempt from the majority of requirements under 21 CFR Part 812. IVD study investigators and members of IRBs who review and approve such studies 6 may also find it helpful. There are also device-specific guidance documents available for specific IVD products that can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm. The use of investigational IVD devices in clinical studies designed to evaluate new drug products falls outside the scope of this guidance. 2. Why are in vitro diagnostics considered devices? In vitro diagnostics (IVDs) meet the definition of a device under the Act. Section 201(h) of the Act defines a device as: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized
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