FDA Roundup: February 2, 2024

SILVER SPRING, Md., Feb. 2, 2024 /PRNewswire/ -- 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.

Additional Resources:

    --  FDA Newsroom

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Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration