Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Story of Digital Health, in “The Fourth Wave: Digital Health Newsletter for Apr 13,” by Paul Sonnier.
Following is an excerpt:
The FDA has released three new guidances on Next Generation Sequencing (NGS) and in vitro diagnostic development. Commissioner Scott Gottlieb’s comments are located here: “Leveraging Innovation for the Treatment of Cancer.”
The FDA has approved IDx’s AI device to detect diabetic eye disease. The system provides a screening decision without the need for a clinician to also interpret the image or results.
The FDA has issued a draft guidance intended to provide device companies with a more flexible iterative approach in applying for 510(k) clearances. FDA Commissioner Scott Gottlieb states that this will: “modernize the FDA’s approach to moderate risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of their new products to legally marketed devices,” The new option also doesn’t require direct comparison to a predicate device as part of a premarket submission.
According to Bradley Merrill Thompson, a member of the firm Epstein Becker & Green, P.C., the FDA has reneged on its promise to take a risk-based approach to CDS software. As Brad writes: “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.”