Category: Standards

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MITA Applauds Senators’ Letter to FDA Regarding Servicing

The Medical Imaging & Technology Alliance (MITA) applauded a recent letter by U.S. senators Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) to acting U.S. FDA Chairman Ned Sharpless, MD, about the agency’s upcoming guidance clarifying the distinction between the “servicing” and “remanufacturing” of medical devices.

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FDA Takes Steps to Modernize 510(k) Medical Device Program

The U.S. FDA has announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices.