The following new items were added to the CDRH web pages on April 2, 2019. Previous CDRH Newitems can be found on the CDRH New webpage.
- Artificial Intelligence and Machine Learning in Software as a Medical Device
- Press Release: Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180024 and DEN180047 added)
- Presentations posted for March 26, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
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