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FDA to launch ICD registry, update GUDID system

The FDA is slated to launch a new national registry of implantable cardiac defibrillators, according to a report from the Regulatory Affairs Professionals Society. The move comes after some reluctance from industry players around the use of unique device identifiers, according to the report. The FDA implemented a final rule in 2013 requiring UDIs on most medical devices, including updated labeling designs and requiring that certain information be submitted to the federal watchdog’s publicly available Global Unique Device Identification Database, RAPS reports. The implementation of a national UDI system helps provide structure to improve best practices, including in care and delivery of medical devices and is especially important for high-risk implantable devices such as ICDs, according to the report. The national registry of ICDs aren’t the only national registry the FDA will be launching this year, RAPS reports, as FDA Center for Devices and Radiological Health head Jeffrey Shuren announced in 2015 that the group was looking to build a National Breast Implant Registry as well. The registry is slated to launch later this year, with the American Society of Plastic Surgeons aiding in the effort. The FDA is also looking to update its GUDID system based on feedback and program needs early next month, according to the reports. Updates include making data in premarket submissions and supplement numbers publicly available. “The premarket numbers provide an essentia...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiac Implants Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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