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The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced Wednesday that it has met its three strategic goals from 2016 and 2017 and it has outlined three more for 2018 to 2022.
Looking ahead to these next three years, CDRH Director Jeff Shuren pointed to three priorities: Better engage the center’s employees and decrease turnover rates, streamline and modernize at least 80% of the center’s processes, and establish new work with a more varied group of stakeholders and companies.
By 31 December 2020, Shuren said CDRH aims to have more than 50% of manufacturers of novel technologies (i.e., devices subject to an original Premarket Approval (PMA) application, panel-track supplements, De Novo classification requests, Humanitarian Device Exemption (HDE), or a premarket notification [510(k)] that is under the breakthrough devices program) bring their devices to the US first or in parallel with other major markets.
"Over the past two years, we have explored, piloted, and developed implementation plans to combine our Office of Compliance, Office of Surveillance and Biometrics, and Office of Device Evaluation into a single 'super office.' This re-organization, which will also include the Office of In Vitro Diagnostics and Radiological Health (OIR), will help us improve information sharing, decision making, and work efficiency by instituting a TPLC1 approach to many of our core activities, similar to how OIR operates today," the report on strategic priorities said.
The strategic priorities also notes collaborative forums for next generation sequencing tests, benefits offered by the Unique Device Identification (UDI) system, a public-private forum established to create a competitive and transparent marketplace around device quality, as part of CDRH’s Case for Quality initiative, and progress made with the National Evaluation System for health Technology.
2018-2020 STRATEGIC PRIORITIES Center for Devices and Radiological Health
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) 2016-2017 STRATEGIC PRIORITIES – ACCOMPLISHMENTS
Tags: novel devices, UDI, NGS