The 2024 Fall ELP Proposal Submission Period is CLOSED
The next ELP Proposal Submission Period will open in February 2024.
On this page:
- What Is CDRH's Experiential Learning Program (ELP)?
- How Is Patient Engagement Integrated into ELP?
- Who Can Apply for CDRH's ELP?
- What Is the Format for a Site Visit?
- What Are the Current Training Areas of Interest?
- How Do I Submit a Proposal?
- How Are ELP Proposals Selected?
The Center for Devices and Radiological Health (CDRH) offers an innovative learning opportunity for new and experienced CDRH staff - The Experiential Learning Program (ELP). Through ELP, CDRH staff have the opportunity to participate in training visits to help close knowledge gaps between emerging and innovative technology and the pre-market review of the resulting medical device.
Formal training visits of the ELP are an opportunity to provide CDRH staff with a better understanding of:
- Products they review
- How products are developed
- The voice of the patient
- Challenges related to quality systems development and management in the product life cycle
- How medical devices fit into the larger healthcare system
These visits are not intended for the FDA to inspect, assess, judge, or perform a regulatory function (for example, compliance inspections).
As technology continuously evolves, CDRH 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 and monitor the performance of marketed devices.
Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning and effective collaborations. CDRH is interested in learning how medical device innovators, developers, manufacturers, distributors, investigators, and others incorporate patient input into a phase or phases of a device's life cycle. Areas where patients may be engaged might include:
- Discovery and ideation
- Invention and prototyping
- Non-clinical testing
- Pre-market clinical testing (for example, trial design and conduct)
- Product launch
- Post-market activities (for example, post-market study design, labeling, and recalls)
CDRH encourages applicants to consider including opportunities to discuss patient perspective and patient engagement as part of ELP proposal submissions. You may select patient engagement as a supplemental topic by checking the Patient Engagement Relevant box in the Sample Site Visit Request document.
Gaining the perspective of our stakeholders and understanding implementation of how these principles are applied within their institutions will provide great insight to the CDRH staff.
CDRH encourages participation from:
- Clinical facilities
- Medical device incubators and accelerators
- Health insurers
- Health technology assessment groups
- Others, including previous participants in the ELP or the FDA's other site visit programs
The ELP is now incorporating virtual site visits into the program in addition to traditional in-person site visits. Virtual site visits allow CDRH to continue participation in the program during periods of limited travel. Virtual site visits also provide greater flexibility in selecting staff for site visits, selecting proposals, and increasing exposure to the program.
The 2024 Fall ELP Proposal Submission Period is now CLOSED. The Training Areas of Interest reflect topics that were identified by CDRH managers.
Before you submit:
- Confirm the Submission Period is OPEN
- Be sure your proposal supports current CDRH training topics of interest.
To prepare and submit a proposal:
- Provide all information included in the Sample Site Visit Request and the Sample Site Visit Agenda.
- To complete the Site Visit Request:
- Proposals should contain only one Training Area of Interest.
- List an Area of Interest along with its Identifier Code.
- To complete the Site Visit Agenda:
- Determine the site visit duration. Proposed agenda may be a single day or multiple days. Note, one- or two-day site visits are most common.
- Indicate your ability to host a virtual site visit.
- To complete the Site Visit Request:
- Submit proposal documents by email to ELP Proposal Submissions by the closing date.
All ELP Proposals are reviewed by CDRH. Site visit selections are made based on factors such as applicability to the areas of interest, CDRH resource availability, and logistical considerations.
Contact ELP Inquiries.