HHS shoots down ‘flawed’ plan to let some devices skip review

Medical Design & Outsourcing – April 15, 2021 – Nancy Crotti

The Biden administration has nixed what it described as a “flawed” Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review.

HHS published the original notice in the Federal Register on Jan. 15, shortly before President Joe Biden was set to take office, without speaking with the FDA before doing so, according to an FDA notice set to appear in the Federal Register tomorrow.

The Jan. 15 notice listed 83 Class II devices and one Class 1 device that HHS had exempted from regulatory review during the COVID-19 public health emergency and proposed making their exemption permanent. They included home ventilators, cardiopulmonary bypass pressure gauges, fetal cardiac monitors, long-term extracorporeal support systems, certain imaging software, ethylene oxide sterilizers and aerators, and certain masks (including N95 respirators), gloves and gowns.

FDA watchdog Madris Tomes, CEO of Device Events, told Medical Design & Outsourcing that she was pleased to learn about the withdrawal of the Jan. 15 decision.

“Although adverse event reports can be used to identify signals (patterns of problems with devices), the absence of these reports does not mean that a device is safe and effective,” Tomes said in an email. “Devices are often under-reported. Further review of the notice in January, that has now been withdrawn, acknowledged that assumption was flawed. It is very understandable that in the midst of the pandemic, that some devices would be authorized for use without the formal 510(k) process. However, assuming that an EUA could replace the typical review process for these devices indefinitely was not a good call by HHS, and I’m glad that Dr. Woodcock’s office has recognized and addressed these flawed exemptions.”

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