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The software update patches the device’s external USB drive performance and its impact on GUI functionality and labeling displayed on the interface during device use. Read More
All site change supplements should clearly identify any changes to manufacturing locations and associated changes to the manufacturing process that result.
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For reclassification proceedings based on new information and proceedings calling for PMAs for a pre-FDASIA class II device, the agency must convene a classification panel and obtain panel recommendations.
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AdvaMed CEO Scott Whitaker called the tax “bad health policy and bad economic policy,” and praised the committee for including the 5-year extension of the moratorium. Read More
Examples of SaMD include software that makes a diagnosis using patient information, X-ray image processing software and smart phone apps that calculate a patient’s required insulin doses using their blood glucose levels. Read More
Final guidance issued by the FDA on Friday outlines what devicemakers should know about manufacturing site changes and when they should submit supplements. Read More
FDA Commissioner Scott Gottlieb said the agency plans to release more details in the coming weeks about its precertification program for digital health technology, including details of the agency’s testing plan for products in 2019. Read More
The FDA issued final guidance on user fees and refunds for device biologics license and premarket approval applications with just minor changes from the October 2017 draft. Read More