Search Site

FDA’s Regulation Of Doctor-Assisting Software Criticized

Much criticism of the U.S. Food and Drug Administration from health care analysts and commentators spotlights alleged overregulation of the medical realm and its adverse effects on both business growth and innovation.

That has once again proven to be true in the response of one industry group to recent FDA-authored draft guidance concerning software that assists physicians treating patients.

The organization Clinical Decision Support Coalition (CDS) has a lot to say about regulators’ proposals that could ultimately be enacted as new rules governing the care-based software.

And most of what the group is passing back to the FDA as feedback is negative. The CDS has a stated aim of protecting clinical software from overregulation while simultaneously promoting patient safety, and it contends that the FDA has a skewed and improper approach to regulation that undermines both those objectives.

A central irritant for the CDS is that the FDA’s guidance calls for a removal of many products already being used in beneficial ways by doctors without any risk-based rationale for doing so. The CDS notes that the FDA worked some time back with global regulators to develop “a risk-based model for software as a medical device,” but is now backtracking from previously reached consensus. Doing so, says the group, adversely affects patient care by taking away useful low-risk devices and programs from doctors.

Additional criticisms are also voiced in a letter the CDS recently offered as a rebuttal to the FDA proposals. Those include a complaint that the federal agency simply doesn’t provide enough examples of what will and won’t be regulated in the future. Readers can see a detailed listing of CDS’s objections by clicking on the highlighted link above.

The organization’s bottom-line concern is this: The FDA guidance materially overregulates, and that benefits neither industry participants nor patients seeking optimal medical care.


1 Memorial Avenue
Pawling, New York 12564
Phone: 845-855-5900
Pawling Law Office Map


102 Gleneida Avenue
Barrister Hall
Carmel, New York 10512
Phone: 845-225-8404
Carmel Law Office Map

Washington, D.C. Office

1140 3rd Street, NE
Washington, District of Columbia 20002
Phone: 202-830-9532
Washington, D.C. Office Map
Contact Us

Contact Form