Regulatory Open Forum

Leveraging the perspective gained during the COVID–19 pandemic, FDA is updating the policy reflected in the "Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency" guidance to exercise certain enforcement policies for certain devices beyond the expiration of the COVID–19 PHE (which expired on May 11, 2023) and the 180-day period announced in the March 13, 2023 Federal Register notice, including by removing clinical thermometers and pulse oximeters from the scope of the guidance, revising the policy with respect to certain device types subject to special controls, and removing use of the term "claims."

Then...

III.Policy
Manufacturers of the non-invasive remote monitoring devices listed in Table 1 are required to submit a premarket notification under section 510(k) of the FD&C Act to FDA and receive FDA clearance prior to marketing these devices in the United States, to the extent the devices are not 510(k) exempt, as well as comply with post-marketing requirements.

As the OEM of a clinical thermometer cleared via 510(k) in 2015 and again in 2020, no longer in Table 1 referenced above, does this guidance alter how FDA is going to regulate our device going forward?

Hi Ed

With the clinical thermometer no longer under the special enforcement policy, I guess it's back to business as usual. If you took advantage of the policy to make changes to the thermometer without filing a new 510k, you may need to catch up now.

Leveraging the perspective gained during the COVID–19 pandemic, FDA is updating the policy reflected in the "Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency" guidance to exercise certain enforcement policies for certain devices beyond the expiration of the COVID–19 PHE (which expired on May 11, 2023) and the 180-day period announced in the March 13, 2023 Federal Register notice, including by removing clinical thermometers and pulse oximeters from the scope of the guidance, revising the policy with respect to certain device types subject to special controls, and removing use of the term "claims."

Then...

III.Policy
Manufacturers of the non-invasive remote monitoring devices listed in Table 1 are required to submit a premarket notification under section 510(k) of the FD&C Act to FDA and receive FDA clearance prior to marketing these devices in the United States, to the extent the devices are not 510(k) exempt, as well as comply with post-marketing requirements.

As the OEM of a clinical thermometer cleared via 510(k) in 2015 and again in 2020, no longer in Table 1 referenced above, does this guidance alter how FDA is going to regulate our device going forward?