Medical Device News Update - July 2024

Note: This article is a summary of the original article published in my Let's Talk Risk! newsletter on Substack, a reader-supported publication. Read the full article here.

Each month, I compile a comprehensive list of medical device news from the prior month, focusing on FDA approvals, warning letters and recalls.

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 for building awareness of gaps in quality management system and the risk management process that should be addressed before they are cited by the FDA.

Quick Summary

New device approvals/clearances

1. Absorbable implant for repair and closure of fistula-in-ano (De Novo DEN240007).
2. A magnetic compression device used to create a side-to-side duodeno-ileal anastomoses (De Novo DEN240013).
3. A self-contained biological indicator for monitoring steam sterilization (De Novo DEN220042).
4. An RT-PCR based assay for detection of C. auris fungal infection (De Novo DEN230092).
5. A hydrogel used to create a physical barrier around a peripheral nerve in patients with trauma or amputation (De Novo DEN230061).
6. An integrated C3F8 ophthalmic gas delivery system for treatment of retinal detachment (PMA, Original, P220030).
7. A blood-based colorectal cancer screening test (PMA, Original, P230009).
8. A total of 251 devices were cleared through the 510(k) process during July 2024. Days to FDA decision ranged from 17 to 1073 days with a median of 115 days. Top 5 medical specialties were General & Plastic Surgery (SU), Orthopedic (OR), Radiology (RA), Dental (DE), and Gastroenterology & Urology (GU) accounting for 62% (155/251) of devices cleared.

Featured Innovation: allay(TM) Nerve Cap

The allay(TM) Nerve Cap from Tulavi Therapeutics is an absorbable hydrogel that is created at the application site to act as a physical barrier separating a peripheral nerve from its surrounding environment after an amputation. This absorbable barrier helps to reduce the risk of a symptomatic neuroma, a growth of nerve tissue that can cause chronic pain and other symptoms in amputees.

According to the company website, there was no neuroma formation across 6 preclinical studies (n >200).

Warning letters

1. Jiangsu Shenli Medical Production Co., Ltd.: Failure to establish and maintain design control procedure, and device master records
2. Jiangsu Caina Medical Co., Ltd: Quality data not used in CAPA, no investigations, failure to conduct adequate design validation and risk analysis.
3. Globus Medical, Inc.: Failure to analyze quality data for CAPA, complaints handling and MDR reporting issues.
4. Criticare Technologies, Inc.: Inadequate procedures for design controls, risk analysis, CAPA, purchasing controls, non-conforming product

Class I recall announcements

1. Philips North America LLC: correction of use instructions for RF coils used in MR scanners for risk of thermal injury due to overheating.
2. Inspire Medical Systems, Inc.: removal of an implantable pulse generator used to stimulate the hypoglossal nerve for treatment of sleep apnea.
3. Hamilton Medical: correction of software issues that may cause the ventilator failure to restart.
4. Megadyne: Soft pediatric return electrode pads for risk of serious burn injuries.
5. Baxter: Ventilator system due to insufficient charging or loss of charge due to battery dongle failure.
6. Bausch + Lomb/Synergetics Inc.: I-Pack ocular injection kits due to potential non-sterility.

For links to each of these updates, click the link below to access the full article.

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