Dive Brief:
- The Food and Drug Administration published an enforcement policy for non-invasive remote monitoring devices on Thursday as part of its transition away from emergency COVID-19 measures.
- Officials freed companies from the need to submit 510(k) filings for some limited modifications to non-invasive remote monitoring devices in March 2020 to help the U.S. cope with the crisis.
- The FDA decided to revise and retain the guidance when the U.S. public health emergency ended earlier this year, leading to updated advice about a shortened list of medical devices that can continue to undergo limited modifications without 510(k) filings.
Dive Insight:
In March, the FDA set out what it planned to do with pandemic-related guidance after the public health emergency ended. The administration identified the enforcement policy on remote monitoring devices as one of the documents that would remain active for 180 days after the end of the emergency. Officials planned to use the time to prepare final guidance based on the emergency documents.
Now, the FDA has published its final guidance on non-invasive remote monitoring devices. The document retains the core aspects of the pandemic-era policy. Both documents allow the manufacturers of certain devices to make limited changes to their products without submitting a 510(k) filing.
The pandemic-era guidance allowed manufacturers of clinical thermometers and pulse oximeters to benefit from the regulatory flexibility. However, the FDA has removed those products from the scope of the final guidance.
The FDA has also revised references to COVID-19 to reflect the end of the public health emergency and reframed the guidance. While the original document was designed to meet needs in the crisis, the FDA is pitching the final guidance as increasing access to digital health technologies “that can advance better care, quality of life and wellness of diverse populations.”
“This policy supports this strategic priority and is intended to lessen the burden on both manufacturers and FDA by reducing the number of 510(k) submissions caused by certain modifications to allow for remote monitoring,” the FDA wrote.
The guidance includes updated advice on the types of modifications that are exempt from 510(k) filings. The FDA cites “modifications to add new indications or device software functions to allow for remote programming of the device” as an example of a change that is outside of the scope of the policy.