lunes, 8 de julio de 2019

Center for Devices Radiological Health (CDRH) Experiential Learning Program (ELP) - Seeking Sites to Participate in the 2020 Training Site Visits – Open: July 8th, 2019 – August 8th, 2019



Center for Devices Radiological Health (CDRH) Experiential Learning Program (ELP) - Seeking Sites to Participate in the 2020 Training Site Visits – Open: July 8th, 2019 – August 8th, 2019


The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) announces the 2020 Experiential Learning Program site visit proposal solicitation period.  The 2020 Fall ELP submission period is OPEN from Monday July 8th, 2019 – Thursday August 8th, 2019 at 12 pm EST’    

The ELP is intended to provide a formal training mechanism for regulatory review staff to visit research, clinical, manufacturing, and health care facilities to observe how medical devices are designed, developed, and utilized.   

The Program has expanded to provide FDA staff with opportunities to better understand policies, laboratory practices, patient input and quality system management.  The ELP is a collaborative effort to enhance communication and facilitation of the medical device review process.  The Center is committed to understanding current industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and quality systems management advance the development and evaluation of innovative devices.

CDRH is inviting medical device companies, academia, and health care facilities to participate in this formal training program.  Details of the Program can be found on the ELP Website, which provides the background, current training needs, and proposal submission process. The training needs will be updated twice a year, in February and July, with a solicitation period for stakeholders to submit training proposals.     

If you have questions regarding the Experiential Learning Program, please contact the ELP Program Manager at ELP@FDA.HHS.GOV, CDRH/OCE Division of Employee Training and Development via email or phone (240) 402-2246.

Thank you for your support.    

Food and Drug Administration
Center for Devices and Radiological Health

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