Guidance for Industry: Guidance for Submission of Immunohistochemistry211 Applications to the FDA

摘要

This guidance document is intended to guide in (1) the processing, content, and211u001eevaluation/approval of submissions for immunohistochemistry devices (IHC's); (2) 211u001ethe design, production, manufacturing, and testing of IHC devices; (3) it 211u001eestablishes for FDA personnel and/or the public policies intended to achieve 211u001econsistency in the agency's regulatory approach; and (4) to serve as the special 211u001econtrol for class II immunohistochemistry (IHC) in vitro diagnostic devices 211u001e(IVDs) under 21 CFR sec. 864.1860. As the special control for class II 211u001eimmunohistochemistry devices (IHC's), this guidance document provides (1) the 211u001etypes and amounts of valid scientific evidence a sponsore should provide to 211u001esupport the reasonable assurance of the safety and effectiveness of the sponsor's 211u001eperformance claims for the IHC device, and (2) a template for acceptable language 211u001eto use in a package insert for IHC devices following 21 CFR section 809.10.