Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Insight, in “Outlook 2023: The Regulatory Path Ahead,” by Elizabeth Orr.

Following is an excerpt:

What regulatory challenges will 2023 bring? Our international panel of top experts has a few guesses.

2023 will be the year of ...

… strong health care industry growth for artificial intelligence. If you've heard that before and therefore are skeptical, you admittedly have good reason to be. There has been a lot of hype. While, according to an AMA survey, the clinical market seems more open now to using AI to help physicians improve the care they provide, perhaps the biggest driver in 2023 is that FDA will move forward with clarifying the regulatory pathway. After many years, FDA has finally set aside the precert program as unfeasible under the current statute. Now, hopefully the FDA will change its focus to working on such initiatives as the predetermined change control guidance to allow AI to morph within parameters without requiring additional agency approval, a huge step forward to making these products commercially feasible.

More Like This

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.