C-MIMI: FDA readies program to speed software reviews
Summary
The program, called Digital Health Software Precertification, is intended to offer a more streamlined and efficient regulatory oversight pathway for software-based medical products.Whats different with the new program is that the focus will be on the software developers demonstrated "culture of quality, operational excellence, and a commitment to monitoring real-world performance" first, rather than on the product, according to Sahiner, who spoke on Monday at C-MIMI 2018, which is sponsored by the Society for Imaging Informatics in Medicine (SIIM).Before a precertified company submits its premarket application, the FDA will identify the type of information needed to review software products for safety and effectiveness.Finally, Sahiner outlined some of the ongoing research DIDSR is doing related to machine learning for image interpretation, including projects on computational lesion insertion for algorithm training and testing, synthetic images and lesions for algorithm training, 3D convolutional neural networks for lung nodule detection, and test data reuse for continuous AI learning."At the FDA, we are actively working to design tools and methods related to machine learning in medical imaging to improve public health," he concluded.