FDA Roundup: February 2, 2024

FDA News Release

• For Immediate Release: February 02, 2024

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

• Today, the FDA issued a safety communication to warn consumers, health care providers, and health care facilities not to use certain Cardinal Health Monoject luer-lock and enteral syringes. Dimensional changes made to the syringes, when used with syringe pumps, PCA pumps, or enteral syringe pumps, may result in recognition, compatibility, and pump performance issues, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. 
• On Thursday, the FDA, in partnership with the Duke-Margolis Center for Health Policy, announced it will convene a public workshop, “Enhancing Adoption of Innovative Clinical Trial Approaches.” The hybrid workshop will be held on Tuesday, March 19 and Wednesday, March 20 both on-site at the Kellogg Conference Hotel (Washington, DC) and virtually. The purpose of the public workshop is to discuss efforts to advance innovation of clinical trial design and conduct. Registration is required for both online and on-site attendance.
• On Thursday, the FDA advised consumers in the Don’t Overuse Acetaminophen Consumer Update to be cautious not to exceed the daily maximum recommended dose of acetaminophen, which can lead to overdose and severe liver damage. Over 600 medications – both prescription and nonprescription – have acetaminophen to help relieve pain and reduce fever.
• On Thursday, the FDA announced the Medical Device Sterilization Town Hall: Premarket Submission Expectations and Additional Considerations for Sterility Review that will be held on February 7, 2024. During this third in a series of medical device sterilization town halls, we will discuss expectations for sterility review for new premarket submissions including recent guidance changes, sterilization modality categories, additional considerations for sterility that impact FDA review, and what to typically include in a submission.
• On Thursday, the FDA approved the Edwards EVOQUE Tricuspid Valve Replacement System, an artificial heart valve that can be implanted using a delivery catheter without open-heart surgery. The EVOQUE valve is intended to treat patients with severely leaky tricuspid valve (tricuspid regurgitation) - often caused by an enlarged heart or damaged native valve flaps (leaflets) - who continue to experience symptoms despite being on heart failure medications. This approval marks the first transcatheter replacement device indicated for use in the tricuspid position. 
• On Thursday, the FDA’s Center for Devices and Radiological Health (CDRH) announced that it is accepting site proposals for the Spring 2024 cycle of the Experiential Learning Program (ELP). Through this collaborative learning experience, sites host CDRH staff (virtually or in-person) and share with them valuable insights about medical devices, emerging technologies, industry practices, regulatory processes, and patient needs.
• On Thursday, the FDA updated the Medical Device Shortages List to remove the following product codes from the shortages list: KDN (system, perfusion, kidney) and KDL (set, perfusion, kidney, disposable).
• On Wednesday, the FDA announced that to address a shortage of FDA-approved Folltropin (follicle stimulating hormone [FSH]), the agency does not intend to object to the temporary importation of Pluset (FSH + luteinizing hormone), by AVL/Solvet. Pluset is authorized for marketing in Spain and importation will improve availability of FSH product for use in cattle in the United States. FSH is an injectable prescription drug used in reproductively mature heifers and cows to induce superovulation, which is an important part of the embryo transfer process. The FDA will reassess the need for continued importation of Pluset as the availability of the FDA-approved product changes.
• On Wednesday, the FDA’s Center for Devices and Radiological Health announced that the center intends to initiate the reclassification process for most in vitro diagnostic (IVD) tests that are currently class III (high risk) into class II (moderate risk). The majority of these tests are infectious disease and companion diagnostic IVDs. Reclassification would allow manufacturers of certain types of tests to seek marketing clearance through the less burdensome premarket notification (510(k)) pathway rather than the premarket approval pathway, the most stringent type of FDA medical device review. Reclassification may support the potential for more manufacturers to develop these tests, which could increase competition and provide patients with increased access to these tests.
   
• On Wednesday, the FDA issued the Quality Management System Regulation (QMSR) Final Rule to ensure medical devices on the market are safe, effective, and of good quality. The QMSR rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements. 
  
  “This final rule is the latest action taken by the FDA to promote global harmonization in device regulation to help assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices both at home and abroad,” said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. “By harmonizing key areas of a medical device manufacturer’s quality management system with the international standard, the
  FDA is streamlining actions device manufacturers must take to meet requirements by multiple regulatory authorities.”
   
• On Wednesday, the FDA authorized marketing of Hologic, Inc.’s Genius Digital Diagnostics System with the Genius Cervical AI algorithm. The device is based on artificial intelligence (AI) technology and is intended for the creation and viewing of digital images of scanned ThinPrep Pap Test glass slides. The device’s AI algorithm presents objects of interest in a gallery format next to the image of the whole cell spot and is intended to aid in cervical cancer screening for the presence of atypical cells, cervical neoplasia, including its precursor lesions, carcinoma, as well as all other cytological categories, as defined by The Bethesda System for Reporting Cervical Cytology. Direct examination of the glass slide by light microscopy should be performed if there is still uncertainty in the diagnosis after reviewing digital images from the device. Digital images from the device should be interpreted by qualified cytologists and pathologists in conjunction with the patient’s screening history, other risk factors, and professional guidelines which guide patient management. 
• On Wednesday, the FDA provided an update on medical device reports it received that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021.
• On Tuesday, the FDA released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. The changes address comments the Agency received on the drafts and provide additional context and information on hazards in food categories of current interest. 
• On Tuesday, the FDA approved Boston Scientific’s FARAPULSE Pulsed Field Ablation (PFA) System to treat paroxysmal atrial fibrillation (Afib) using electrical pulses to ablate cardiac tissue. The system has several components, including a generator and a catheter that ablate tissue with fast electrical pulses that form holes in the thin membrane around each cell (irreversible electroporation) instead of with thermal energy. The FDA granted Breakthrough Device designation to the FARAPULSE PFA system because it represents a breakthrough technology that could provide more effective treatment for a life-threatening or irreversibly debilitating condition, among other criteria. This approval brings to market another alternative treatment modality that may reduce risks seen with conventional thermal ablation for the treatment of Afib.
• On Monday, the FDA announced the availability of draft guidance for industry titled, “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.” The purpose of this guidance is to provide the FDA’s expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical trials and clinical studies for FDA-regulated medical products. Using standard terminology for race and ethnicity helps ensure that data are collected and reported consistently in submissions to the FDA. This draft guidance revises the final guidance for industry and FDA staff entitled "Collection of Race and Ethnicity Data in Clinical Trials" issued on October 26, 2016.