New Developments in FDA Regulation of AI
CONCLUSION
On the whole, FDA seems very enthusiastic about the possibilities for AI to improve healthcare. Thatâs gratifying to see. While progress in the development of a new regulatory approach is slow, thatâs also not all bad. It would be worse in many ways for FDA to act precipitously. These are complicated issues, and it will take time to develop an appropriate approach, in part because it will take time for FDA to acquire enough expertise. And most likely, whatever new approach we come up with will require new statutory authority. That said, it is incumbent on all of us to work as quickly as we can to bring these exciting new developments to waiting patients. The possible improvements to patient care are enormous.
References
Clinical Decision Support Software Draft Guidance for Industry and FDA Staff, September 2019, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software.
Section 201(h) of the Food, Drug & Cosmetic Act (21 U.S.C. 321(h))
Agenda for Quarterly Meeting on MDUFA IV (FY 2018-2022) Performance November 15, 2019, page 277 https://www.fda.gov/media/132770/download.Â
"FDA still trying to fine-tune Pre-Cert as pilot enters 2020," Medtech Dive, March 2020, https://www.medtechdive.com/news/fda-pre-cert-software-device-pilot-enters-another-year/574822/
Proposed Regulatory Framework for Modifications to Artificial Intelligen...
Source: MDDI - Category: Medical Devices Authors: Bradley Merrill Thompson Tags: Regulatory and Compliance Source Type: news
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