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Experiential Learning Program (ELP) Areas of Interest

The proposal submission period for the 2026 cycle of the Experiential Learning Program (ELP) is now OPEN.

The 2026 ELP Training Areas of Interest (shown below) are for reference only. Additional areas of interest may be added periodically as needs are identified.

Submit proposals by June 18, 2026 for FY26.

The following table provides the current Experiential Learning Program (ELP) Areas of Interest. Important items to note for this proposal solicitation period include:

  • Virtual Site Visits: The Experiential Learning Program is implementing virtual site visits alongside the traditional on-site option. This will allow greater flexibility in selecting staff for site visits, selecting proposals, and helping to increase exposure to the program. If your organization can accommodate a virtual site visit for any of the Areas of Interest for which a proposal is being submitted, please indicate this when completing the Site Visit Request (for example, Site Visit Request Sample).
  • Patient Engagement: If your organization would like to submit a proposal for any Areas of Interest stated in the 2026 table below, please consider including Patient Engagement as a potential supplemental topic to the Area of Interest for which you are applying. You may do this by checking the "Patient Engagement Relevant" box in the Site Visit Request Sample.

On this page:

Home as a Health Care Hub

The FDA has an interest in learning how devices are developed and tested for use in heterogeneous home environments. Home environments encompass any non-clinical environment where lay users operate medical devices without direct professional supervision. This includes understanding how companies are designing and evaluating their devices for use by patients and caregivers in the home, the validation approaches involving “simulated home laboratories,” and the quality management systems that ensure consistent performance across varied home environments. Interest includes focus on understanding the unique challenges posed by device use with little to no clinician oversight in home environments and how manufacturers address these challenges throughout the device lifecycle.

Device Design and Development for the Home Environment

The FDA has an interest in learning how manufacturers incorporate home environments, different users (e.g., patients, caregivers, family members with various degrees of health and digital literacy), and intended use considerations into device design from initial concept through final product deployment. This includes understanding user-centered design and human factors/usability engineering approaches used to design for heterogeneous user populations, the methods for identifying and mitigating risks related to device use with minimal clinician oversight, and the design features applied to support that devices function safely and effectively across different home environments with variable environmental characteristics (e.g., varying lighting, sound, temperature, humidity, space constraints, potential interference from household items). Interest extends to understanding how companies balance device complexity with ease of use, how they design user interfaces and instructions for the intended users, and how they incorporate feedback from intended users throughout the design process.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 A1

Medical Device Interoperability and Systems-Level Safety Assessment

There is an interest in learning more about how manufacturers design, verify, and validate medical devices intended to interoperate with other devices or health IT systems, particularly understanding the approaches to system-level risk management when device boundaries span multiple manufacturers. We are interested in understanding how collaborative development models, standardized interface approaches, and platform-based architecture allocate safety responsibilities across interoperable components, and how manufacturers demonstrate that interface specifications, communication protocols, and data exchange mechanisms are adequate for their intended use. Risk assessment and mitigation strategies in dealing with emerging challenges such as data quality and context preservation across interfaces, device interchangeability testing, semantic interoperability through standards like IEEE 11073 and HL7 FHIR, and user-centered design for multi-device system complexity particularly in home environments are elements to address. Additionally, understanding how manufacturers apply consensus standards (AAMI UL 2800 series, IEEE 11073 families, IEC 60601 collateral standards) to demonstrate safe interoperability, and how system-level verification and validation is conducted when components may be mixed and matched in configurations not fully tested during premarket review, are key areas of focus.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 A2

Simulated and Real-World Home Environment Validation Strategies for Home-Use Devices

The FDA has an interest in learning about the full spectrum of validation strategies used to evaluate home-use devices, ranging from controlled simulated home laboratory environments to real-world testing in actual home settings. Simulated home laboratories — which may include physical lab spaces or virtual/augmented reality environments designed to replicate realistic home conditions such as apartments, single-family homes, or multi-generational households — offer companies a controlled yet realistic setting in which to evaluate device performance, inform design modifications, and develop risk mitigation strategies; the FDA's learning interests include understanding how these environments are designed and configured, the protocols and test methods employed, and how companies validate that simulated conditions adequately represent real-world home environments, including the advantages, limitations, and criteria used to determine when simulated testing is sufficient versus when actual home testing is necessary. Complementing this, the FDA is also interested in understanding validation strategies that involve testing devices in actual home environments with intended users, including study design considerations, participant recruitment strategies that ensure representation of heterogeneous user populations, data collection methods that minimize disruption to daily routines, and approaches for monitoring safety and effectiveness over extended use periods — as well as how companies address logistical challenges, maintain participant engagement, ensure safety during unsupervised use, and incorporate real-world findings into device improvements and post-market surveillance strategies.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 A3

Device Manufacturing and Validation

The FDA has an interest in the manufacturing processes, process validation, and manufacturing change assessment which may be related to reviews of Investigational Device Exemption (IDE), Premarket Approval (PMA), and 30-day notice submissions.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 B1

Management of Device Clinical Studies

The FDA has an interest in real-world perspective on the conduct of medical device clinical studies, including but not limited to clinical infrastructure, the roles/responsibilities of all parties involved in the study (sponsor, investigator, study subjects, Institutional Review Boards (IRB), Contract Research Organization (CRO).

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 C1

Artificial Intelligence/Machine Learning (AI/ML)

The FDA has an interest in the application of AI/ML to evaluate device outputs, as well as gaining a deeper understanding of device monitoring, governance, and risk mitigation across the AI device lifecycle. This encompasses how companies are addressing challenges such as system drift, local variability, and post-deployment performance specifications across diverse care settings, including the collection and use of real-world data, as well as how clinical sites are assessing and validating the accuracy and utility of AI software within their own environments.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 D1

Drug Delivery Devices

The FDA has an interest in learning more about drug delivery devices (e.g., autoinjectors, on-body delivery systems), including design/development, verification/validation, manufacturing, and risk management considerations.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 E1

Unique Device Identification (UDI) Implementation in Healthcare

The FDA has an interest in the process of UDI implementation in healthcare facilities. Specifically, the workflow of UDI in healthcare facilities' supply chain (purchasing, Inventory management, and UDI capture at the point of patient care), its support for their ROI, and how UDI is being utilized for medical device recalls and adverse events once the UDI system is in place.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 F1

Infection Control (Reprocessing)

The FDA has an interest in the reprocessing of reusable medical devices.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 G1

Robotically Assisted Surgical Devices (RASD) Workflow

The FDA has an interest in learning more about the clinical workflow, cybersecurity, and tele-operations of robotically assisted surgical devices (RASD), including those used to perform neurosurgical and neurointerventional procedures.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 H1

Surgical Planning Software and Patient Specific Guides and their Clinical Use

The FDA has an interest in learning the end-to-end process for patient-matched surgical guide manufacture and use, encompassing surgical case planning, patient image acquisition and quality control, software and interface utilization, guide creation, surgeon verification, manufacturing, testing, and intraoperative application.

  • Anticipated participants: Cross Cutting
  • Identifier: 2026 J1

Application of In Vitro Diagnostic (IVD) Devices in a Clinical Laboratory Setting

The FDA has an interest in learning how devices that have received marketing authorization and CLIA categorization are incorporated into a laboratory setting.

  • Anticipated participants: Cross Cutting
  • Identifier: 2026 K1

Hands on Exposure with Anesthesia Devices

The FDA has an interest in hands on exposure and experience with anesthesia medical devices such as anesthesia machines, gas monitors, laryngoscopes, and airways.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2026 L1
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