Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, and Jason Brooke, an associate in the Health Care and Life Sciences practice, in the Washington, DC, office, co-wrote an article titled, "FDA's Approach to Clinical Decision Support Software: A Brief Summary."
Following is an excerpt:
We wrote this paper for those who have little experience with U.S. Food and Drug Administration regulation of clinical decision support (CDS) software. Our goal is to provide background for those who want to participate in FDA's ongoing efforts to clarify its regulatory approach to CDS. In 2011, FDA announced plans to publish a new guidance document that will define which types of CDS it will regulate. To gather the information needed to write the guidance, the agency held a hearing in September 2011, and we anticipate FDA will propose its guidance document perhaps early in 2012.
