Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Health Data Management, in “FDA to Create Centralized Digital Health Unit,” by Greg Slabodkin.

Following is an excerpt:

Bradley Merrill Thompson, an attorney at Washington-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, says that industry has long supported medical device users fees and the concept of an FDA digital health unit.

“On the whole, industry has been hoping that FDA would create this office for years, and indeed it was a specific recommendation of the FDASIA working group a few years ago, so it is great that it will finally come to be,” Thompson notes.

At the same time, he warns that the problem for the agency will be recruiting staff for the digital health unit. “Right now salaries for people in those domains are sky-high, and that means many folks are very nervous about how FDA will succeed in recruiting the talent it needs,” adds Thompson. “For example, machine learning is a key knowledge base that FDA should have going forward, but machine learning people are in extremely scarce supply.”

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.