HHS eliminates “flawed” plan to let some devices skip review

April 16, 2021 – 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 to the FDA before doing so.

The 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.

The exemptions 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.

The Jan. 15 notice also did not list any limitations to the 84 proposed exemptions or indicate that HHS considered whether any such limitations were appropriate, the new notice adds. It did, however, generate “many comments and inquiries asking about various potential errors and ambiguities, such as about mismatched product descriptions, product codes, and regulatory citations,” according to the new notice penned by HHS Secretary Xavier Becerra and acting FDA commissioner Janet Woodcock.

In its original notice, HHS said it based its exemption decisions on a review of adverse events reported to the FDA MAUDE database about the types of devices between 2010 and 2020. The devices recommended for permanent exemption accounted for 46 deaths reported to MAUDE, including 16 related to facility-use apnea monitors. The original notice proposed to exempt 50 class II device types based solely on a lack of death-related adverse event reports available in MAUDE for the time period searched, while failing to consider adverse event reports submitted under other event types, including “injury” and “malfunction,” Becerra and Woodcock wrote.

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