Medical Device News Update - August 2023

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

Monthly roundup of FDA approvals, warning letters and recalls issued in August 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 the benefit-risk of devices when reviewing their safety and effectiveness. Warning letters and recall announcements are useful to study to build awareness of gaps in quality management system and the risk management processes 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.

---

Quick Summary

1. New device approvals/clearances

   1. A machine learning-based software to analyze ECG data (De Novo)

   2. An implantable device to manage urge urinary incontinence (De Novo)

   3. A device to facilitate drainage of the gallbladder into the bowel (De Novo)

   4. A device to reduce radiation exposure to adjacent pelvic tissues during treatment of cervical cancer (De Novo)

   5. POLARx (TM and POLARx FIT (TM) cryoablation balloon catheters for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PMA, original, P22032).

   6. A total of 314 devices were cleared through the 510(k) process during August 2023. Days to clearance ranged from 1 to 723 with a median of 141 days. Top 5 medical specialties were Orthopedic (OR), Cardiovascular (CV), General & Plastic Surgery (SU), General Hospital (HO) and Radiology (RA), accounting for 59% (185/314) of devices cleared.

2. FDA warning letters

   1. Tesla BioHealing, Inc - marketing without FDA approval or clearance. Lack of a Quality Management System in compliance with the Quality System Regulation.

   2. King Systems Corp. - marketing without FDA approval or clearance.

3. Class I recall announcements

   1. There were a total of 10 Class I announcements on the FDA’s website

      1. Datascope/Maquet/Getinge: 6 separate Class I recalls associated with the Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps.

      2. Philips Respironics: Trilogy ventilators recall due to dust/dirt in air path.

      3. Abiomed: inadequate precautions in the IFU.

      4. Draeger: contaminants in the air path of pediatric ventilators.

      5. Hamilton Medical: ventilator software issue/alarm which may lead to unexpected shutdown.

Let us take a closer look.