Medical Device News Update - February 2024

FDA approvals, warning letters and Class I recalls issued during February 2024

Monthly roundup of FDA approvals, warning letters and recalls issued in February 2024

Each month, Let’s Talk Risk! (LTR) provides a comprehensive summary of new device approvals or clearances, warning letters, and Class I recall announcements issued by the FDA in the previous month.

As a risk practitioner, it is very important to stay up to date with the latest regulatory developments affecting the medical device industry. A review of latest innovations approved or cleared by the FDA helps in understanding different ways the agency evaluates benefit-risk of medical devices when reviewing their safety and effectiveness. Warning letters and recall announcements are useful to study for awareness of gaps in quality management system and the risk management process that should be addressed before they are cited by the FDA.

Only publicly available information is curated in this article. Links to relevant sources are referenced in the footnotes.

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Quick Summary

1. New device approvals/clearances

   1. A mobile app for detection of sleep apnea (De Novo DEN230041).

   2. A mechanical device to assist with temporary embolization of aneurysms in the peripheral vasculature (De Novo DEN230064).

   3. A miniaturized robotic assisted surgery device for minimally invasive colectomy procedures (De Novo DEN230025).

   4. An enzyme activity assay to aid in diagnosis of thrombotic thrombocytopenic purpura (TTP) rare blood clotting disorder (De Novo DEN230024).

   5. Edwards EVOQUE Tricuspid Valve Replacement System (PMA, Original, P230013).

   6. Xstim Spine Fusion Stimulator (PMA, Original, P230025).

   7. AGENT™ Paclitaxel-Coated Balloon Catheter (PMA, Original, P230030).

   8. A total of 219 devices were cleared through the 510(k) process during February 2024. Days to FDA decision ranged from 1 to 791 days with a median of 136 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Cardiovascular (CV), and Neurology (NE) accounting for 58% (127/219) of devices cleared.

2. FDA warning letters

   1. There were no warning letters issued to medical device firms by the FDA during the month of February 2024.

3. Class I recall announcements

   1. There were a total of 4 Class I announcements on the FDA’s website

      1. Percussionaire: product defect in a kit used for continuous ventilation of patients may lead to over-pressurization.

      2. Smiths Medical ASD Inc.: software issues with an older version in a syringe pump used for infusion may cause interruption or delay in therapy.

      3. Philips: component failure may cause the detector in an imaging system to unexpectedly fall on the patient.

      4. Wipro GE Healthcare Private Ltd.: incubator door latch may not close securely, which may lead to an infant falling out of the incubator.

Let us take a closer look.