EMERGO SUMMARY OF KEY POINTS:

• The US FDA has launched an Experiential Learning Program (ELP) for premarket review staff to learn more from industry about medical device manufacturing and quality processes.
• The FDA’s Center for Devices and Radiological Health (CDRH) is soliciting participation in the ELP from manufacturers, academia, research institutes and insurers.
• Firms interested in participating in the first phase of the ELP have until April 30, 2017 to submit proposals.

The US Food and Drug Administration is rolling out a new program whereby regulatory staff learn about new and innovative medical device technologies from industry to enhance premarket reviews and other regulatory processes.

The FDA’s Center for Devices and Radiological Health (CDRH) has now formally called for industry participants in its Experiential Learning Program, or ELP. Under the program, CRDH staff would pay formal training visits to participating manufacturers, research facilities and related sites to learn about issues including quality management, patient and user input and product lifecycle management. Such training would enable CDRH staff to conduct more efficient and informed premarket reviews of new and cutting-edge devices, according to the agency.

Training separate from other regulatory functions

The CDRH’s call for ELP participants claims that training visits to industry sites will be strictly for education 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,” states the announcement.

How medical device companies can participate in the ELP

Potential participants identified by the CDRH include device manufacturers, academia, clinical facilities, incubators and health insurance companies.

On a quarterly basis, CDRH staff will identify areas of interest—research and development, reimbursement coverage, manufacturing processes—in which agency staff would benefit from observing operations. Interested firms and sites should preview identified areas of interest and submit proposals (Sample Site Visit Request and Sample Site Visit Agenda templates) to the regulator.

Submissions are currently being accepted through April 30, 2017.

Related services and resources from Emergo:

• US FDA consulting services for medical device companies
• US FDA Pre-Sub consulting for medical device registrants
• Whitepaper: FDA regulations for novel and innovative devices