May 11, 2021

As we reported in January, a statement in the Federal Register ascribed to both the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) announced the permanent exemption of seven types of Class I medical devices from 510(k) premarket notification requirements. At the same time, the announcement proposed exemptions for 83 Class II medical device types and one unclassified type. This action was intended in part to ensure an adequate supply of products needed for the COVID-19 pandemic and to allow the FDA to focus on more critical regulatory activities. The proposal was opened up to public comment over a 60-day period.

In a follow-up notice published in the Federal Register on April 16, the agency (along with the HHS) has officially withdrawn the proposed exemptions. The notice credited both internal FDA and external analysis of the measure for producing convincing arguments that the exemptions were inappropriate. The notice of withdrawal cites inadequate communication between the HHS and FDA, faulty evidence of device safety, and improper criteria for determining which devices would be eligible for exemption. A companion notice indicated that the FDA and HHS have jointly determined that the permanent exemptions of Class I devices already in place was likewise based on flawed reasoning.

Reasons for the withdrawal of proposed exemptions of Class II medical devices from 510(k) requirements

The issue of inadequate communication between government bodies takes center stage. Although the January notice in the Federal Register claimed to represent both the FDA and HHS, this notice clarifies that HHS apparently formulated and published it without consulting or even notifying the agency. The list of device types to be exempted included products that are critical for supporting life, and the primary criterion for exemption was a lack of adverse event reports for a given device type in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

The FDA’s Center for Devices and Radiological Health (CDRH) approached HHS after the January notice with concerns about the methods used for determining exemption eligibility, and the agency reports that “dozens” of stakeholders raised issues through the public consultation or via e-mailed communication to the government bodies. Many of these objections argued that a lack of adverse event reporting in MAUDE is not sufficient to establish that a device may be used safely and effectively. Underreporting and misattribution of adverse events are common problems known to the FDA, and some commenters additionally noted that a lack of reported adverse events may indicate low usage of a device type rather than any positive indications of its safety. This evaluation method also ignored alternate sources of data pertaining to device safety, such as recall notices.

Beyond the problems with limiting analysis to adverse event reports in MAUDE, the notice finds that even this data was examined too narrowly. 50 Class II device types were marked for exemption because of a lack of reported adverse events resulting in death during the time period examined, but adverse events with other marked outcomes including “injury” or “malfunction” were not counted. Established FDA guidelines for whether 510(k) premarket notification is necessary emphasize the need to consider all reports reflecting on a device’s safe operation, even if problems have not been major enough to kill patients.

Finally, the withdrawal notice states that HHS analysis focused solely on safety while failing to evaluate the effectiveness of the listed device types. It points to previous discussion of criteria for the exemption of Class II medical devices from 510(k) requirements, as described in a past Federal Register notice and in the guidance document Procedures for Class II Device Exemptions from Premarket Notification. There is a strong precedent for conducting a thorough analysis of device effectiveness before making any decisions about exemption.

US FDA and HHS reevaluate exemption for designated Class I medical devices

The other notice in the Federal Register revisiting the exemption from 510(k) premarket notification requirements for seven Class I medical device types relies on similar reasoning. This measure largely applied to surgical and examination gloves, which the FDA and HHS cite here as being critical to patient safety. This notice points to the excessively short duration of time in which adverse event reports were collected and the high likelihood that reporting was especially difficult given the circumstances relating to the COVID-19 pandemic.

The impact on medical device manufacturers and importers of reversing a previously announced exemption constitutes an additional dimension of analysis in this notice. The FDA and HHS conclude that few stakeholders will have committed to long-term investments or contracts based on placing the designated devices on the US market in the few months that have elapsed since the January notice. Any negative impact on industry would thus fail to outweigh the public health utility of removing the exemptions for these Class I devices.

Related COVID-19 and US FDA medical device regulatory resources:

  • COVID-19 regulatory news and analysis resource center
  • US FDA 510(k) consulting for medical device and IVD companies
  • FDA Emergency Use Authorization (EUA) support for medical device and IVD manufacturers
  • Webinar: FDA EUA for medical devices and IVDs
  • Webinar: Mapping cybersecurity standards to FDA guidance

Author

  • Timothy Herr

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