The CDRH acknowledges that they don’t know everything about the medical devices that they regulate. So they have called up the medical industry to help educate them. The Experiential Learning Program (ELP) is asking manufacturers, researchers, laboratories and others to invite the CDRH staff on a series of field trips to show them about the actual in’s and out’s of medical devices.
This is a voluntary program which the CDRH hopes will make them better regulators and close the knowledge gaps that currently exist.
The initial March 11, 2017 memo announcing this program explains that these visits are not for the purpose of the FDA to inspect, judge or perform any regulatory function, but for the CDRH staff to better understand the products that they review, how they are developed, the voice of the patient, and how they fit into the larger healthcare system.
The memo further points to specific areas of interest and sample agendas.
(I am paraphrasing the CDRH’s formal announcement, so please read the original to make sure I said things correctly.)
The ELP Public Site can be found at: ELP Public Website Link
The Federal Register Notice can be found at: 2017 ELP Federal Register Notice