FDA Roundup: June 30, 2023

FDA News Release

• For Immediate Release: June 30, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Thursday, the FDA’s Center for Tobacco Products (CTP) Director Brian King published a statement summarizing the center’s progress 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 also available at the updated webpage, Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP.
• On Thursday, the FDA accepted the first master file for participation in the 510(k) Ethylene Oxide (EO) Sterility Change Master File Pilot Program. As a result, 510(k) holders of devices labeled as sterile that wish to begin using Andersen Sterilizers EO-Flexible Chamber Technology (EO-FCT) systems to sterilize authorized class I or class II devices may reference the Andersen Sterilizers master file rather than submitting a new 510(k) for the sterilization change. Andersen Sterilizers sterilization system uses a customizable small chamber, which requires less EO than established EO systems, supporting the agency’s goal of minimizing the use of EO. For more information, see Master Files | FDA. See also Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff (fda.gov).
• On Thursday, the FDA granted marketing authorization of Renalytix AI, Inc.’s KidneyIntelX.dkd, an in vitro diagnostic intended to aid in the assessment of risk of progressive kidney function decline in adult patients with Type 2 diabetes and existing chronic kidney disease. KidneyIntelX.dkd works by measuring three analyte components associated with kidney function decline from a patient’s plasma sample. The results of the three measured analytes are combined with three data inputs from the patient’s medical record provided by the ordering physician, and a machine-learning algorithm provides a risk category of low, moderate, or high. KidneyIntelX.dkd is not intended for screening or as a stand-alone diagnostic test.
• On Thursday, the FDA approved the AAV5 DetectCDx, a companion diagnostic test intended to aid in identifying patients who may benefit from receiving gene therapy with ROCTAVIAN to treat an inherited bleeding disorder in which the blood does not clot properly due to a very low level of a certain coagulation factor (hemophilia A). 

“Together, the AAV5 DetectCDx and ROCTAVIAN, offer another treatment option for certain patients  living with hemophilia A, a disorder that adversely impacts their everyday lives due to the increased risk of uncontrolled bleeding,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics in the FDA’s Center for Devices and Radiological Health. “Today’s approval furthers the FDA’s ongoing commitment to advancing the availability of companion diagnostic devices, which provide information that is essential for the safe and effective use of a corresponding therapeutic product.” 

The FDA reviewed data from numerous studies to ensure that the AAV5 DetectCDx was appropriately reliable and effective at detecting pre-existing anti-AAV5 antibodies. Pre-existing anti-AAV5 antibodies may render the gene therapy less effective or ineffective. Clinical study data from hemophilia A patients who received ROCTAVIAN after being identified as eligible by the AAV5 DetectCDx (patients without pre-existing anti-AAV5 antibodies), supported the safety and effectiveness of the AAV5 DetectCDx for its intended use as a companion diagnostic to ROCTAVIAN. The FDA granted approval of the AAV5 DetectCDx to ARUP Laboratories.

• On Wednesday, the FDA provided an update to information and recommendations for titanium-based NuVasive Specialized Orthopedics’ (NuVasive) Precice Intra-medullary Limb Lengthening (IMLL) system, which includes Precice Short, to ensure health care providers are aware of the current indications and the Instructions for Use for the IMLL system. The IMLL system can be used for limb lengthening of the tibia and femur in pediatric patients greater than 12 years old. The Letter to Health Care Providers includes:
  • Recommendations for health care providers
  • Unique Device Identifier information
  • Actions the FDA continues to take to evaluate potential biocompatibility concerns with all Precice devices
  • Instructions for reporting problems to the FDA.