欧盟指导原则 Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs) Draft Points to Consider Regarding Labeling and Premarket Submissions (Text Only).docxVIP

Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions (Text Only) This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s. Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions Center for Devices and Radiological Health October 1988 I. Purpose The purpose of this document is to assist prospective manufacturers, producers, and marketers (hereinafter called manufacturers) of home-use in vitro diagnostic devices (IVDs) in complying with existing labeling regulations, e.g., 21 CFR 801.5, 809.3(a) and 809.10, and premarket clearance requirements, e.g., Sections 510(k) and 515 of the Federal Food, Drug, and Cosmetic Act (the Act), and regulations including 21 CFR Parts 807 and 814. This document addresses home-use testing kits and home-use mail-in specimen collection kits. II. Background In vitro diagnostic devices (IVDs) as defined in 21 CFR 809.3(a) are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent