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.