Medical Device News Update - December 2023

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

Monthly roundup of FDA approvals, warning letters and recalls issued in December 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. An external mechanical stimulator to relive nasal congestion (De Novo).

   2. A software to analyze GI capsule images obtained during endoscopy (De Novo).

   3. An app to measure body temperature using a smartphone (De Novo).

   4. A software to predict liver tissue response after an ablation procedure for post-treatment (De Novo)

   5. A pulse field ablation system for treatment of atrial fibrillation (PMA, Original, P230017).

   6. A DNA-based assay and sample collection kit for detection of opioid use disorder (PMA, Original, P230032).

   7. A portfolio of stents for customized treatment of chronic venous insufficiency (CVI) (PMA, Original, P230021).

   8. An occluder implant for closure of secundum type atrial septum defect (PMA, Original, P200032).

   9. A total of 312 devices were cleared through the 510(k) process during December 2023. Days to FDA decision ranged from 1 to 649 with a median of 128 days. Top 5 medical specialties were Radiology (RA), Orthopedic (OR), Cardiovascular (CV), General & Plastic Surgery (SU), and Dental (DE) accounting for 60% (186/312) of devices cleared.

2. FDA warning letters

   1. Fresenius Medical Care AG & Co. KGaA: CAPA and design validation issues, failure to report field correction/removal

3. Class I recall announcements

   1. There were a total of 7 Class I announcements on the FDA’s website

      1. Eitan Medical: failure to detect air in the infusion pump line.

      2. BD/Carefusion: incompatibility of Monoject syringe with the Alaris infusion pump modules.

      3. Cordis: inadequate sterilization of an angiographic catheter.

      4. Getinge: failure to crank an emergency drive of an external blood purification system.

      5. Medtronic: software issues with a surgical navigation system.

      6. Olympus USA: risk of fire with bronchoscopes.

      7. Philips North America: risk of explosion with certain MRI systems.

Let us take a closer look.