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MITA Raises Questions With Pre-Cert Software Pilot - Enviro Led Tech
The Medical Imaging & Technology Alliance (MITA) this week raised questions about the value of participating in a new US Food and Drug Administration (FDA) Pre-Certification pilot for software as a medical device (SaMD) products. While noting how an increasing number of SaMD products are coming to market to be used in the diagnosis and treatment of medical conditions, MITA Executive Director Patrick Hope says the alliance supports efficient FDA oversight to allow products to come to market more quickly. “It is unclear, however, in what way and to what extent Pre-Cert will actually accomplish this,” he says, noting the costs associated with the program for participants, which include developing more rigorous post-market surveillance systems and sharing different kinds of