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  1. FDA STEM Outreach, Education and Engagement

CDRH's Experiential Learning Program (ELP)

The 2024 Fall ELP Proposal Submission Period is OPEN
August 3, 2023, at 9am ET - September 5, 2023, at 12PM ET.

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What Is CDRH's Experiential Learning Program?

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.

How Is Patient Engagement Integrated into ELP?

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.

Who Can Apply for CDRH's ELP?

CDRH encourages participation from:

  • Companies
  • Academia
  • 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

What Is the Format for a Site Visit?

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.

What Are the Current Training Areas of Interest?

The Training Areas of Interest reflect topics identified by CDRH managers. They are listed on the website twice a year during the two Fiscal Year ELP Training Submission Periods.

Sites interested in ELP participation are encouraged to preview the identified Training Areas of Interest before beginning a proposal.

View the 2024 Fall ELP Areas of Interest

How Do I Submit a Proposal?

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.
  • Submit proposal documents by email to ELP Proposal Submissions by the closing date.

How Are ELP Proposals Selected?

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.

Questions

Contact ELP Inquiries.

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