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FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing On May 10, the FDA released two discussion papers on the use of artificial intelligence and machine learning (AI/ML) in drug development and manufacturing. In a statement introducing the papers, Patrizia Cavazzoni, M.D., Director of the FDA Center …
Software and Artificial Intelligence as a Medical Device Earlier this month, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) issued the guidance document, “Software and Artificial Intelligence as a Medical Device.” The guidance brings together current guidances, advice and regulatory requirements for Software as a Medical Device (SaMD) and Artificial Intelligence as a …
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FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices On March 30, the FDA’s Center for Devices and Radiological Health (CDRH) published a draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” Per the FDA’s announcement, the draft guidance …
The Turing Test is Dead In May 2018, Google showcased a demo of Google Duplex, an AI-based technology that engages in real-world conversations to carry out simple tasks. The demo brought to mind some of Steve Jobs’ famous product keynotes, as Google Duplex was used to book a hair appointment over the phone with …
FDA Announces Funding Opportunities for Medical Device Development Tools The FDA Center for Devices and Radiological Health (CDRH) has announced new funding opportunities to support small businesses in developing innovative medical device development tools (MDDTs). The MDDT program was created in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse …
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