CDRH Seeks Participants in On-Site Staff Training Program for Medical Devices
Posted March 30, 2017
Medical device companies and other stakeholders have until April 30 to apply to be a part of a Food and Drug Administration (FDA) program intended to help federal regulators better understand medical devices.
The Experiential Learning Program (ELP), which began in 2012, is for Center for Devices and Radiological Health (CDRH) staff who are tasked with reviewing medical device applications. The goal is to help them better understand how these devices are designed, tested, manufactured, used, and how they impact patient care.
“The ELP is a collaborative effort to enhance communication and facilitate the premarket review process,” CDRH wrote in an email announcement. “The center is committed to understanding current industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and quality systems management advances the development and evaluation of innovative devices.”
According to a Federal Register notice, the program involves CDRH staff visiting companies and clinical facilities to learn more about the products they review. The main areas of interest for staff visits include biocompatibility, combination products, clinical trials, digital health/software, import shipping facilities, in vitro diagnostics, manufacturing, postmarket assessment, quality management, reprocessing and sterilization, standards conformity assessment testing, and innovation.
The agency said it also was interested in learning more about how participating organizations incorporate two of CDRH’s strategic priorities―partnering with patients and promoting a culture of quality and organizational excellence―into the device development life cycle.
The FDA stressed that ELP visits were purely for training purposes.
“These formal training visits are not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), but rather, they are an opportunity to provide CDRH review staff a better understanding of the products they review, how they are developed, the voice of the patient, challenges related to quality systems development and management in the product life cycle, and how medical devices fit into the larger healthcare system,” the FDA wrote in the notice.
Medical device manufacturers, academic institutions, healthcare facilities, medical device incubators and accelerators, health insurers, health technology assessment groups, and others are encouraged to apply using the process described on the ELP website.