A series of recent US Food and Drug Administration (FDA) policy commitments in the medical device space is building up the pressure of a staff training program being extended into 2019.
The Experiential Learning Program (ELP) is designed for staff at FDA’s Center for Devices and Radiological Health (CDRH) to gain a better understanding of issues facing firms throughout a total product life cycle, based on new experiences and observations from conducting site visits.
FDA has continued to extend ELP each year since its 2013 implementation
, banking on the lessons learned from the formal training to meet certain goals set to achieve a specified vision.
The focus shifted toward simplicity, collaborative communities and employee engagement with CDRH’s latest policy roadmap
. But the goals set forth for the next three years add to the previous mission on partnering with the patient community as the same promises remain.
The submission period for companies to propose site visits was opened on 24 August and is set to close on 26 September. CDRH's training needs for ELP 2019 were also made public last week.
The new training needs template
provides more examples and detailed explanations of the specific areas of interest and device types compared to the one prepared for this year's program. Most of the newly identified needs are under the areas of device development, including the use of quality controls, and digital health.
Specific new topics within device development include continuous glucose monitoring systems and insulin pumps, next-generation sequencing as well as point-of-care diagnostic devices and accessories. Under digital health, new topics relate to advanced analytics, artificial intelligence, cloud-based products, medical device data systems, mobile medical apps, among others.
An entirely new area of interest was added on innovation and market access. "FDA staff would benefit from a better understanding of how innovators consider the needs of and engage with professional societies, healthcare providers, healthcare technology assessment groups, and payors," according to the template.
Article updated on 8/29 for information on the new submission period.