Authority To Collect Performance Data, Reform of How the FDA Evaluates Devices May Be in the Works
Dennis Tosh
March 6, 2024 at 06:59 PM EST
A recent Government Accountability Office (GAO) report on the regulatory and legislative problems posed by emerging technologies offers a glimpse into possible upcoming changes in how the FDA authorizes and oversees medical devices that incorporate artificial intelligence (AI) or machine learning (ML) capabilities.
The report — “Federal Regulation: Selected Emerging Technolog...
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