The U.S. Food and Drug Administration (FDA) provided an update on various developments within the agency on June 30, 2023.
Firstly, the FDA’s Center for Tobacco Products (CTP) Director Brian King shared a statement summarizing the center’s progress in addressing the evaluation of CTP by an independent expert panel facilitated by the Reagan-Udall Foundation (RUF). A comprehensive list of status updates for each recommendation is available on the FDA’s website.
Additionally, the FDA accepted the first master file for participation in the 510(k) Ethylene Oxide (EO) Sterility Change Master File Pilot Program. This program allows holders of devices labeled as sterile to reference the Andersen Sterilizers master file, rather than submitting a new 510(k), if they wish to use Andersen Sterilizers EO-Flexible Chamber Technology (EO-FCT) systems to sterilize authorized class I or class II devices. The Andersen Sterilizers system uses a customizable small chamber that requires less EO, aligning with the FDA’s goal of minimizing EO usage.
The FDA also granted marketing authorization to Renalytix AI, Inc.’s KidneyIntelX.dkd. This in vitro diagnostic is intended to aid in the assessment of the risk of progressive kidney function decline in adult patients with Type 2 diabetes and existing chronic kidney disease. KidneyIntelX.dkd measures three analyte components associated with kidney function decline and combines the results with three data inputs from the patient’s medical record using a machine-learning algorithm to provide a risk category. However, this diagnostic is not intended for screening or as a stand-alone test.
In addition, the FDA approved the AAV5 DetectCDx, a companion diagnostic test for identifying patients who may benefit from receiving gene therapy with ROCTAVIAN to treat hemophilia A. The AAV5 DetectCDx detects pre-existing anti-AAV5 antibodies, which can affect the effectiveness of the gene therapy. Clinical study data supported the safety and effectiveness of the AAV5 DetectCDx when used as a companion diagnostic to ROCTAVIAN. Approval for the AAV5 DetectCDx was granted to ARUP Laboratories.
The FDA also provided an update on titanium-based NuVasive Specialized Orthopedics’ Precice Intra-medullary Limb Lengthening (IMLL) system. The update includes information and recommendations for health care providers regarding the current indications and instructions for use of the IMLL system, specifically the Precice Short variant.
In summary, the FDA’s recent updates include progress in addressing the evaluation of CTP, acceptance of the first master file for the EO Sterility Change Pilot Program, marketing authorization for KidneyIntelX.dkd, approval of the AAV5 DetectCDx as a companion diagnostic for ROCTAVIAN, and an update on the IMLL system. These developments reflect the FDA’s commitment to ensuring the safety and effectiveness of various medical products.
