As discussed in an earlier blog post, US President Donald Trump signed the Further Consolidated Appropriations Act, 2020, into law on December 20, 2019, which includes bipartisan legislation intended to facilitate the development of generic and biosimilar products. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act enhances access by generic manufacturers to brand-name drug samples for the development of generic versions.
The US Food and Drug Administration (FDA) recently issued new draft guidance on clinical decision support (CDS) software that revamps the agency’s interpretation of the 21st Century Cures Act and proposes new policies of enforcement discretion for some categories of CDS software. In a recent LawFlash, Morgan Lewis partner Michele Buenafe details key takeaways from the revised guidance, which is a significant departure from the 2017 draft.
We invite you to join us in Houston on September 12 for our Second Cup of Coffee breakfast series covering the latest legal developments in digital health and healthcare innovation. In Siri Goes to Medical School – The Rise of AI in Healthcare, partners Susan Feigin Harris, Michele Buenafe, and Andrew Ray will discuss what is happening in the world of artificial intelligence and healthcare, including recent developments, legal trends, and FDA regulatory hurdles.
If you are interested in registering, please contact Stefani Cornwall. Space is limited—reserve your spot now!
Could a new FDA regulatory approach for postmarket changes to artificial intelligence (AI)/machine learning (ML)–based software devices be in our future? A recent discussion paper offers important insight into the FDA’s thinking on reducing postmarket burdens for FDA cleared or approved AI/ML technologies. Given that the FDA has yet to develop clear guidance on when AI/ML technologies are subject to regulation, could the FDA’s proposal to address postmarket changes for these technologies be putting the cart before the horse?
Read the full LawFlash for more in-depth analysis on FDA’s discussion paper.
Did you catch our most recent edition of Fast Break? If not, we had an awesome extended session with Michele Buenafe on May 16 that was also part of our annual Technology May-rathon series. Michele described how the FDA is treating various types of software and hardware that may have healthcare functions as well as certain clinical decision support systems. Michele discussed some of the new and innovative ways that the FDA is trying to regulate—perhaps with a lighter hand—various AI and software systems that have historically had challenges with FDA oversight.