The FDA’s 5-Year Delay on Automated Medicine Must End


Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in VentureBeat, titled “The FDA’s 5-Year Delay on Automated Medicine Must End.”

Following is an excerpt:

On September 30, the federal government ended another fiscal year without publishing a much-needed –  and supposedly top priority – guidance on clinical decision-support software (CDS). The agency has been working on this guidance for five years, but it still hasn’t published anything. To be clear, the FDA does regulate some high-risk CDS, and it should. But for small companies developing products in the space, the question naturally is: Where is the dividing line? Without guidance, no one knows the answer to that simple question. So how is an entrepreneur to develop a business plan and obtain funding if she can’t answer that simple question for investors?