Medical Device News Update - November 2024

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

Monthly roundup of FDA approvals, warning letters and recalls issued in November 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 in building 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 provided in the footnotes.

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Quick Summary

New device approvals/clearances

1. An infusion cannula to deliver gene therapy treatment in the brain tissue (De Novo DEN240023).

2. A qualitative test to detect residual soil protein on a cleaned medical device prior to disinfection or sterilization (De Novo DEN230085).

3. A device to deliver light energy to the eye for treatment of age-related macular degeneration (De Novo DEN230083).

4. A stent system for treatment of carotid artery stenosis in high risk patients(PMA, Original, P210030).

5. An integrated platform for treatment of atrial fibrillation (PMA, Original, P240006).

6. A next gen sequencing based companion diagnostic test for various cancer therapies (PMA, Original, P240010).

7. A total of 260 devices were cleared through the 510(k) pathway during November 2024. Days to FDA decision ranged from 2 to 1279 days with a median of 110 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Cardiovascular (CV), and Dental (DE) accounting for 67% (173/260) of devices cleared.

FDA warning letters

1. Owens and Minor, Inc.: Quality system violations - incoming product inspection, design controls, failure to conduct verification and validation for 25 FDA product codes.

Class I recall announcements

1. Percussionaire: risk of exposure to aerosolized nickel during normal use of a ventilator.

2. Getinge and Maquet: risk of silicone detachment from a vessel harvesting tool used in minimally invasive endoscopic surgery.

3. Smiths Medical: risk of infusion pump battery pack melting or failing to recharge due to damage.

4. Philips: risk of aerosol deposits on internal flow sensor in various ventilator models.

5. Draeger, Inc.: risk of piston ventilator failing due to a manufacturing error.

6. Elekta: risk of microscopic stainless steel debris on brain biopsy needles.

7. FHC: manufacturing defect resulting in out of spec cannula used in micro-targeting electrode insertion sets during neurosurgery.

8. Baxter: risk of exposure to PCBs and PCBAs from silicone tubing used in dialysis machines.

Let us take a closer look.