Medical Device News Update - March 2024

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

Monthly roundup of FDA approvals, warning letters and recalls issued in March 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. A skin harvesting system using Autologous Regeneration of Tissue technology (De Novo DEN210049).

   2. An in-vitro device to characterize cell types in bone marrow smears for diagnosing hematologic diseases. (De Novo DEN230034).

   3. An in-vitro device to detect Parvovirus B19 infection (PMA, Original, P220034)

   4. A total of 280 devices were cleared through the 510(k) process during March 2024. Days to FDA decision ranged from 1 to 1079 days with a median of 135 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Cardiovascular (CV), and Neurology (NE) accounting for 56% (157/280) of devices cleared.

2. FDA warning letters

   1. Agena Bioscience, Inc.: Marketing a new or modified device without FDA approval or clearance.

   2. Jiangsu Shenli Medical Production Co., Ltd.: Marketing of a medical device without FDA approval or clearance through a US distributor.

   3. Medline Industries, LP: Marketing of medical devices from foreign distributor without FDA approval or clearance. Additional quality system violations in design controls, complaints handling and CAPA.

   4. Beckman Coulter Inc.: incorrect harm severity assignments in risk analysis, underestimating risk, CAPA and NC procedures.

3. Class I recall announcements

   1. Datex-Ohmeda: air compressors used in certain ventilators due to elevated levels of formaldehyde emissions.

   2. Smiths Medical ASD Inc.: software issues with an older version in a syringe pump used for infusion may cause interruption or delay in therapy.

   3. Baxter Healthcare: pharmacy mixing systems due to a software error.

   4. Medtronic Neurosurgery: cerebral spinal fluid drainage catheter due to potential for disconnecting.

   5. Ventec Life Systems: breathing package for pediatric patients due to a manufacturing issue.

   6. Windstone Medical Packaging: convenience kits containing potentially non-sterile saline involved in another recall by Nurse Assist.

   7. Abbott: HeartMate touch connection system for unintentional pump start and stop.

   8. Avanos: feeding kits containing potentially non-sterile saline involved in another recall by Nurse Assist.

   9. Abiomed: Impella left sided blood pumps due to perforation risks.

   10. Vyaire: AirLife manual resuscitators due to manufacturing defect that can cause a malfunction.

   11. Medline Industries: convenience kits containing potentially non-sterile saline involved in another recall by Nurse Assist.

Let us take a closer look.