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The FDA has issued a draft guidance intended to provide device companies with a more flexible iterative approach in applying for 510(k) clearances.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.”

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.