Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in multiple publications on the topic of the FDA’s new regulatory guidelines, released on December 7, 2017, for digital health devices and clinical decision support.
Following is an excerpt from FierceHealthcare, “After A 6-Year Wait, FDA’s Clinical Decision Support Guidelines Get a Mixed Reaction,” by Evan Sweeney.
- HealthcareDive, “FDA Debuts New Clinical Support Software Draft Guide, Backs Off Certain Regulations,” by David Lim.
- Politico Morning, “FDA Digital Health Guidance Aftermath,” by Darius Tahir.
- MobiHealthNews, “FDA Issues Three Guidances, Including Long-Awaited CDS Guidelines,” by Jonah Comstock.
- Health Data Management, “FDA Issues Draft Guidance on Clinical Decision Support Software,” by Greg Slabodkin.
- CNBC, “The Feds Just Cleared a Major Roadblock for Digital Health,” by Christina Farr.
- Bloomberg BNA Medical Devices Law & Industry Report, “FDA Plans to Exempt Some Health Software from Device Rules,” by James Swann. (Read the full version – subscription required.)
- Inside Health Policy, “FDA OKs First Medical Device For Use With Apple Watch After 19-Month Review,” by Nicholas Florko. (Read the full version – subscription required.)
- Medtech Insight, “Draft Clinical-Decision-Support Software Guide Paves A Path, But May Need Some Work,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
- MedCityNews ,“FDA Digital Health Draft Guidance Scales Back Regulation of Certain Types of Software,” by Stephanie Baum.
- Rodexo,“FDA Guidance on Clinical Decision Support Clears Digital Health Block.”