• Regulatory NewsRegulatory News

    CDRH Seeks Participants for Staff Training Program

    Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices.  The training program, which is not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), is "is intended to provide CDRH ...
  • Regulatory NewsRegulatory News

    FDA to Device Industry: Teach us More About Diagnostics and Sequencing

    The US Food and Drug Administration's (FDA) medical device regulators are once again preparing to expand a program they use to learn about cutting-edge and essential medical technologies, this time with a particular focus on in vitro diagnostics and next generation sequencing (NGS) technology. Background The program FDA has proposed to extend is known as the Experiential Learning Program (ELP), and was first proposed in September 2011 by FDA's medical device regulatory ...
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    FDA Wants its Regulators to Learn More About 3D Printing, Other Device Topics

    The US Food and Drug Administration (FDA) announced this week that it plans to expand a program it uses to better understand the real-world challenges of the medical device industry it regulates. The ELP Program FDA's Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort to reform the Center for Devices and Radiological Health (CDRH) in light of criticism that the center was too out of touch with challenges faced by device manu...
  • FDA Extends Program in Hopes of Helping its Regulators Learn More About the Device Industry

    The US Food and Drug Administration (FDA) is once again extending a program intended to help its medical device review staff to better understand the regulatory process from the perspective of the industry it regulates. The ELP Program The program, known as the Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort for reforms at the Center for Devices and Radiological Health (CDRH) intended to accommodate criticism from industr...