Medical Device News Update - January 2024

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

Monthly roundup of FDA approvals, warning letters and recalls issued in January 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. An AI-based handheld device to aid in diagnosis of skin cancer (De Novo).

   2. A wearable belt to reduce decline in bone strength through mechanical vibrations (De Novo).

   3. A digital diagnostic imaging system using AI to identify cancerous cells in Pap smear slide samples (De Novo).

   4. Defibrillation electrodes and accessories (PMA, Original, P200005).

   5. A TAMBE device for endovascular repair in patients with thoracoabdominal aortic aneurysms (PMA, Original, P230023).

   6. A pulsed field ablation (PFA) system for treatment of drug-refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PMA, Original, P230030).

   7. A total of 212 devices were cleared through the 510(k) process during January 2024. Days to FDA decision ranged from 27 to 887 with a median of 134 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Gastroenterology & Urology (GU), and Dental (DE) accounting for 60% (127/212) of devices cleared.

2. FDA warning letters

   1. Barkey GmbH & Co. KG: Introducing a new version of a cleared device without submitting a premarket notification to the FDA.

3. Class I recall announcements

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

      1. Insulet Corporation: software issue that may lead to insulin overdose.

      2. Megadyne Medical Products, Inc.: burn injuries associated with use of soft patient return electrodes requiring new limitations in the IFU.

      3. Busse Hospital Disposables, Inc.: trays and kits used in tracheostomy supplied with a recalled component.

      4. ResMed Ltd.: masks containing magnetic fasteners when used with CPAP or BiPAP machines may cause interference with other medical devices including implants.

      5. Fresenius Kabi USA: mechanical issues in an infusion pump may lead to system shutdown.

      6. ROi CPS, LLC: single use kits used in various surgical procedures supplied with a recalled, potentially non-sterile component.

      7. Globus Medical, Inc.: calibration issues in a component of a surgical guidance system may lead to device misplacement during surgery.

      8. Maquet Cardiovascular, LLC.: chest drain kits supplied with a recalled, potentially non-sterile component.

Let us take a closer look.