FDA to Industry: “Teach Us”

The FDA wants device makers to invite the agency’s premarket review staff into their facilities to learn about industry practices.

The agency promises these formal training visits are not intended for agency staff to inspect, assess, judge, or perform a regulatory function such as compliance inspection.

Experiential Learning Program (ELP)

In 2017, the FDA’s Center for Devices and Radiological Health (CDRH) started the Experiential Learning Program (EL), for new and experienced review staff to learn about the real-world problems of device makers. The agency wanted to partner with industry to help reviewers understand the “policies, laboratory and manufacturing practices, and the challenges addressing patient perspective/input, quality system management, and other challenges that impact the device development life cycle.”

The agency said it recognized a knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices. “Because technology continuously evolves, it is essential that CDRH review staff members are aware of and understands how medical devices are developed, clinically tested, manufactured, and used.”

CDRH encourages participation from companies, academia, and clinical facilities, medical device incubators and accelerators, health insurers, health technology assessment groups, and others, including those that have previously participated in the ELP or other FDA site visit programs.

Application Process

If you’d like to participate in the program, while establishing great contacts within the agency, you can submit a proposal during the Submission Period for proposal submissions. The Submission Period Status is currently open until noon on September 26, 2018.

You may submit a proposal to the program by following the instructions on this link.

Typically, one site visit will address one Area of Interest and can last one or more days.

The Areas of Interest include:

• Biocompatibility
• Combination products
• Clinical trials/clinical research
• Device development/manufacturing/device demonstration
• Digital health/software
• Innovation/health technology assessment/market access
• InVitro diagnostics
• Quality management/quality systems
• Standards conformity assessment testing

You may email your proposal to elp@fda.hhs.gov.

If you have any questions regarding submitting a proposal or any ELP related questions, you may contact ELP Management at ELP Inquiries or (240) 402-2246.