Regulatory Focus™ > News Articles > 2021 > 4 > FDA walks back Trump-era premarket notification exemptions

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Posted 15 April 2021 | By Michael Mezher 

FDA walks back Trump-era premarket notification exemptions

2909 The US Food and Drug Administration (FDA) on Thursday took steps to undo a sweeping deregulatory move that was pushed through by the Department of Health and Human Services (HHS) in the final days of the Trump administration.
With less than a week left in the previous administration, HHS published a notice in the Federal Register exempting seven types of surgical and patient examination gloves and proposing to permanently exempt more than 80 Class II devices and one unclassified device from premarket notification requirements. (RELATED: HHS pushes through last-minute policies impacting FDA, Regulatory Focus 12 January 2021; Device, digital health firms oppose HHS’ proposed 510(k) exemptions, Regulatory Focus 23 March 2021).
While all the devices listed in the notice were subject to temporary enforcement policies during the COVID-19 public health emergency (PHE), FDA says it and HHS have reviewed the 15 January 2020 notice and determined that the reasoning behind the exemptions was flawed. (RELATED: FDA eases regulatory requirements on surgical gowns, gloves, Regulatory Focus 30 March 2020).
Not only did the previous administration base its determination for the exemptions and proposed exemptions solely on adverse events in FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, it also did not consult with experts at FDA on whether the devices should be exempted.
As such, in two new Federal Register notices, FDA says it is withdrawing the proposed exemptions and seeking comment on the exempted gloves listed in the previous notice before making a final determination on those devices.
“Based on the risks inherent with surgeon’s gloves and patient examination gloves and the diseases being prevented, FDA’s experience with these devices, and other relevant considerations, HHS and FDA believe that gloves with the product codes LYY, LYZ, OIG, OPC, OPH, LZC, and OPA are intended for uses which are of substantial importance in preventing impairment of human health or present a potential unreasonable risk of illness or injury and thus require a report under section 510(k) of the [Federal Food, Drug and Cosmetic Act] FD&C Act,” FDA writes, adding that 510(k) review is necessary to provide reasonable assurance of safety and effectiveness for such products.
FDA explains that it determined that surgeon’s gloves and patient examination gloves meet the reserve criteria for Class I medical devices subject to 510(k) requirements in the late 1990s and again in 2017 when reviewing Class I devices following the passage of the 21st Century Cures Act. (RELATED: FDA identifies more than 70 Class I devices now exempt from 510(k) requirements, Regulatory Focus 12 April 2017).
The agency further notes that the temporary enforcement policy lifting certain requirements for the gloves “is fundamentally different from a determination that the gloves no longer meet the reserve criteria or otherwise no longer require a 510(k) [and] was issued in response to a highly unusual set of facts and circumstances: the most sweeping PHE to occur in over a century.”
In addition to highlighting several flaws in the reasoning behind the 15 January notice, FDA points out that the notice created regulatory uncertainty for glove makers.
“HHS and FDA observe that … the Notice contained a number of flaws that have led to significant questions about the status of these devices. HHS and FDA have not only received over 60 inquiries about the Notice, reflecting a pattern of uncertainty, but have also received requests for review of 510(k) premarket notifications that have been voluntarily submitted for such devices. Based on these facts, HHS and FDA believe that only a limited subset of regulated entities may have placed legitimate reliance on the January 15, 2021, Notice,” FDA writes.
In a separate notice, FDA says it is withdrawing the portion of the 15 January notice that proposed to exempt 83 Class II and one unclassified device from premarket notification requirements.
Here, FDA points out that its temporary enforcement policies during the COVID-19 PHE were intended to provide limited regulatory flexibilities for products that have already submitted premarket notification. In each of the enforcement policies, FDA said it does not intend to object to certain modifications of the devices or their intended use to ease regulatory burdens during the pandemic.
Federal Register notices: Medical Devices; Class I Surgeon’s and Patient Examination Gloves, Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices from Premarket Notification Requirements; Withdrawal of Proposed Exemptions


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