Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Medical Device and Diagnostic Industry (MDDI) Online, in “FDA Issues Emergency Guidance for Non-Invasive Remote Monitoring Devices,” by Daphne Allen.
Following is an excerpt:
The policy outlines several acceptable modifications. For instance, Bradley Merrill Thompson, a member of the firm, Epstein Becker & Green, P.C., pointed out that FDA is “allowing hardware used in remote monitoring to be marketed with expanded claims that may include reference to the particular coronavirus disease 2019. That’s very helpful,” he wrote in an email to MD+DI. “There are a lot of people looking for solutions in telemedicine and remote monitoring who may be able to use a broader set of products than those that have been specifically cleared for this use previously.” He also said that the agency is allowing some hardware modifications to make them more suitable for the current need, such as adding Bluetooth or other connectivity means. “This, too, is very sensible and should not add much risk,” he wrote.
FDA’s temporary policy also acknowledged that software, including mobile apps, may also prove useful in patient monitoring during the pandemic. The agency points out that The 21st Century Cures Act amended FDA regulations to exclude certain software functions from the definition of a medical device, including certain clinical decision support (CDS) software functions. Thompson pointed out that with this emergency policy “FDA is waiving the limitation on CDS for the present emergency to allow the development of clinical decision support products that offer advice on diagnosing and treating coronavirus disease 2019. There are limits of course,” he wrote. “They recommend what I think are very practical labeling statements to help the user understand how the product can be used and how it shouldn’t be used.”