Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “FDA Steps on Gas for Digital Health,” by Darius Tahir.
Following is an excerpt:
FDA is getting more active on the digital health front amid the coronavirus crisis: …
The agency is easing enforcement on remote patient monitoring devices and clinical decision support software related to coronavirus, in a Friday. Such products, ideally, can allow providers to better manage patients from afar, keeping people from infecting or being infected.
For devices, manufacturers can make “limited” label modifications if those changes are related to coronavirus, though manufacturers will have to delineate which claims are FDA-cleared and which are expansions, along with providing data about the justifications for those claims. This might clear products intended for hospital use to be moved into the home, for example.
Manufacturers can also effectively turn on features, like wireless or Bluetooth, provided they build in cybersecurity controls.
Commenters on the guidance were bullish. Epstein Becker & Green digital health lawyer Bradley Merrill Thompson said in an email that the guidance is “very practical and doesn’t open the floodgates wide to potential fraudsters,” saying it should support “people looking for solutions in telemedicine and remote monitoring.”
