Medical Device News Update - September 2023

FDA approvals, warning letters and recalls issued during the month of September 2023

Monthly roundup of FDA approvals, warning letters and recalls issued in September 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 whole room microbial reduction UV robot (De Novo).

   2. A mechanical device to prevent injury to the esophagus during catheter ablation (De Novo).

   3. A temperature regulation device inserted through the esophagus during catheter ablation (De Novo).

   4. a device to create a more stable arteriovenous fistula for dialysis (De Novo).

   5. 2 diagnostic assays for measurement of monoclonal antibodies used in treatment of cancer, Crohn’s disease and ulcerative colitis (De Novo).

   6. a diagnostic panel to detect common hereditary markers for certain cancers (De Novo).

   7. LimFlow system to help reduce the risk of amputation in patients with insufficient blood flow to their limbs (PMA, original, P220025).

   8. a cross-seal suture-mediated vascular closure device system (PMA, original, P210017).

   9. a companion diagnostic test for patients undergoing treatment with Vectibix (panitumumab) (PMA, original, P220005).

   10. A total of 315 devices were cleared through the 510(k) process during September 2023. Days to FDA decision ranged from 1 to 1278 with a median of 146 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), Cardiovascular (CV), General & Plastic Surgery (SU), and General Hospital (HO) accounting for 55% (173/315) of devices cleared.

2. FDA warning letters

   1. Abiomed, Inc - marketing without FDA approval or clearance. QMS issues with CAPA, complaints and adverse reporting, and corrections/removal process.

3. Class I recall announcements

   1. There were a total of 5 Class I announcements on the FDA’s website

      1. Mallinckrodt Manufacturing: Class I recall of a one-way valve not opening properly.

      2. Abbott Medical: Class I recall of Proclaim and Infinity IPGs for inability to exit magnetic resonance imaging (MRI) mode.

      3. Medline Industries: Class I recall of saline solution vial due to being non-sterile.

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

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

Let us take a closer look.