Medical Device News Update - October 2023

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

Monthly roundup of FDA approvals, warning letters and recalls issued in October 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.

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Quick Summary

1. New device approvals/clearances

   1. A solution used for flushing and storage of the saphenous vein grafts (De Novo).

   2. An ultrasound device for non-invasive destruction of liver tumors (De Novo).

   3. Aurora ICD system for treatment and prevention of life-threatening ventricular tachyarrhythmias (PMA, original, P22012)

   4. A total of 311 devices were cleared through the 510(k) process during October 2023. Days to FDA decision ranged from 10 to 864 with a median of 125 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), Cardiovascular (CV), General & Plastic Surgery (SU), and Dental (DE) accounting for 58% (181/311) of devices cleared.

2. FDA warning letters

   1. Neurotris, Inc: marketing without FDA approval or clearance. QMS issues with design validation, CAPA process, non-conforming product and supplier evaluation.

   2. Wavi Co.: marketing without FDA approval or clearance. QMS issues with software validation, process validation, device history records, device master records and quality audits.

3. Class I recall announcements

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

      1. Hamilton Medical: Class I recall of ventilators for capacitor fluid leaks and short circuits.

      2. Philips Respironics: Class I recall of ventilators due to power management printed circuit board assemblies not meeting ventilator standards.

      3. Fresenius Medical: Class I recall of dialysis machines for potential of exposure to PCBAs.

      4. Olympus: Class I recall of high flow insufflation unit for over-inflation of air into the body with no warning or alarm. 

Let us take a closer look.