Medical Device News Update - May 2024

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

Monthly roundup of FDA approvals, warning letters and recalls issued in May 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 to build 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 AI/ML enabled device for home use by patients with neovascular age-related macular degeneration for review by their ophthalmologist (De Novo DEN230043).

2. A smart phone app for remote monitoring of orthodontic treatments and treatment progress (De Novo DEN230035).

3. A digital sensor and monitoring system for physical/chemical sterilization processes (De Novo DEN230068).

4. A breakthrough device for qualitative detection of colorectal neoplasia associated with RNA markers and for the presence of occult hemoglobin in human stool. (PMA, Original, P230001).

5. A total of 279 devices were cleared through the 510(k) process during May 2024. Days to FDA decision ranged from 7 to 872 days with a median of 167 days. Top 5 medical specialties were General & Plastic Surgery (SU), Orthopedic (OR), Radiology (RA), Cardiovascular (CV), and Dental (DE) accounting for 59% (165/279) of devices cleared.

FDA warning letters

1. Cue Health, Inc.: Marketing of COVID-19 tests with unauthorized changes, shipping product with inadequate quality control.

Class I recall announcements

1. Tandem Diabetes Care, Inc.: Version 2.7 of iOS t:connect mobile app due to software error leading to pump battery depletion.

2. Route 92 Medical Inc.: medical delivery catheters due to distal tip separation.

3. Philips Respironics, Inc..: Trilogy Evo ventilators due to software related power malfunction.

4. Abbott: Heartmate 3 LVAS implant kit for risk of blood leakage or air entry between inflow cannula and apical cuff.

5. Hologic, Inc.: BioZorb markers due to complications with implanted devices.

6. Vyaire Medical, Inc.: Twin tubes due to the potential of nozzle separating during use on a patient undergoing a stress test.

7. OptumHealth Care Solutions.: Nimbus II infusion pumps related to another recall due to multiple potential failure modes.

Let us take a closer look.