FDA Reneged on Its Promise to Take a Risk-Based Approach to CDS Software


Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in MobiHealthNews, titled, “FDA Reneged on its Promise to Take a Risk-Based Approach to CDS Software.”

Following is an excerpt:

Since the Medical Device Amendments of 1976, a hallmark of FDA’s regulation of medical devices has been the agency’s risk-based approach. Medical technology covers everything from tongue depressors to pacemakers, so one size of regulation simply does not fit all. By law, FDA is supposed to focus its limited resources on higher risk technologies both to maximize public health protection, and at the same time to avoid stifling innovation where regulation is unnecessary. Unfortunately, in developing its new approach to regulating clinical decision support (CDS) software, FDA has chosen to ignore that basic principle as well as a promise the agency made to Congress and the public.