FDA Deploys 'Elsa' AI Tool to Accelerate Medical Device Reviews Amid Budget Cuts

TL;DR
The FDA's new AI tool, CDRH-GPT, still in beta, faces significant issues such as bugs, connectivity problems, and inaccuracies, raising concerns about rushing AI deployment in medical device review processes amid staff layoffs and safety considerations.
- FDA’s AI tool for medical devices struggles with simple tasks NBC News
- FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People fda.gov
- FDA launches agency-wide AI tool ‘Elsa’ ahead of schedule Regulatory Affairs Professionals Society | RAPS
- US FDA launches AI tool to reduce time taken for scientific reviews Reuters
- FDA, facing 4% budget cut, launches generative AI tool Elsa a month ahead of schedule Fierce Biotech
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