Medical Device News Update - November 2023

FDA approvals, warning letters and Class I recalls issued during November 2023.

Monthly roundup of FDA approvals, warning letters and recalls issued in November 2023

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.

---

Quick Summary

1. New device approvals/clearances

   1. An in-vitro test for detection of 2 sexually transmitted diseases (De Novo).

   2. Infant pulse rate and oxygen saturation monitoring device (De Novo).

   3. An in-vitro device for enrichment of CD138+ cells from bone marrow collected from patients diagnosed with multiple myeloma (De Novo).

   4. Renal denervation systems for treatment of hypertension (PMA, Original, P220026 and P220023).

   5. An in-vitro assay for detection of HPV (PMA original, P230003).

   6. A total of 253 devices were cleared through the 510(k) process during November 2023. Days to FDA decision ranged from 1 to 1094 with a median of 133 days. Top 5 medical specialties were Radiology (RA), Orthopedic (OR), General & Plastic Surgery (SU), Cardiovascular (CV), Gastroenterology & Urology (GU) accounting for 60% (151/253) of devices cleared.

2. FDA warning letters

   1. Wello, Inc: labeling issues, missing UDI, failure to submit required information for the GUDID database.

3. Class I recall announcements

   1. There were a total of 8 Class I announcements on the FDA’s website

      1. Teleflex and Arrow International: mislabeling of pressure injectable catheters.

      2. Covidien, LLC: stolen defective video laryngoscope in the market.

      3. Cardinal Health: incompatibility of syringes with certain syringe pumps due to dimensional changes.

      4. Baxter Healthcare: potential under-dosing of medication due to software error.

      5. Fresenius Medical: leakage in syringes used during hemodialysis treatment.

      6. Asenus Surgical: uncontrolled movement of the robotic-assisted surgical arm due to defective component.

      7. B. Braun Medical: faulty occlusion alarms in infusion pumps.

      8. Unomedical A/S: unexpected detachment of connectors during insulin delivery due to manufacturing defect.

Let us take a closer look.