Department of Health and Human Services December 18, 2017 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces an opportunity for commercial manufacturers to work with CDC's National Center for Immunization and Respiratory Diseases (NCIRD) on the validation of pertussis serological kits prior to submission to the Food and Drug Administration (FDA) for marketing authorization. CDC is interested in the development of an assay that is an Immunoglobulin G (IgG) anti-pertussis toxin (PT) enzyme-linked immunosorbent assay (ELISA), calibrated to an international reference standard (such as FDA Reference Standard Lot #3, World Health Organization (WHO) International Standard 06/140, or equivalents). The ELISA will be used for in vitro serological diagnosis of pertussis in clinical cases of selected age groups. CDC will be able to provide guidance, materials, and evaluation support for the manufacturer; however, the manufacturer will be responsible for submitting a premarket submission to FDA with adequate information, including any analytical or clinical data needed to support the submission, to demonstrate to FDA that FDA can grant marketing authorization to the product.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Investigational IVDs Used in Clinical Investigations of Therapeutic Products.'' This draft guidance is intended to assist sponsors of clinical investigations of therapeutic products that also include investigational in vitro diagnostics (IVDs) and institutional review boards (IRBs) that review such investigations in complying with the Investigational Device Exemption (IDE) regulation. This draft guidance is also intended to assist FDA staff participating in the review of these investigations. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.'' FDA is issuing this draft guidance document to update and clarify the policy for a manufacturer's application of an assay that was previously cleared for use based on performance characteristics with a specified instrument, to an additional instrument that was previously cleared or that is a member of an instrument family from which another member has been previously cleared. When finalized, this document will supersede ``Replacement Reagent and Instrument Family Policy,'' issued on December 11, 2003. This draft guidance is not final nor is it in effect at this time.