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Experiential Learning Program (ELP) Areas of Interest

The proposal submission period for the 2025 Fall cycle of the Experiential Learning Program (ELP) is open through Oct. 7, 2024, at noon EST.

The following table provides the Fall FY 2025 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 now 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 Fall 2025 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:

Biocompatibility

Good Laboratory Practice Animal Safety Studies

Good Laboratory Practice (GLP) animal safety studies are a critical component of premarket reviews. This area of interest is centered around visiting an animal facility that regularly performs GLP studies for medical devices to learn about the conduct of animal safety studies, to observe a surgical or interventional procedure in a large animal model (to better understand the personnel, equipment, monitoring, and animal model limitations), to observe a necropsy evaluation and discuss the histopathology evaluation, and to learn about the integration of the GLP regulations into the test facility and study conduct.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 A1

Globalization of Animal Safety Studies

This area of interest is related to the coordination of animal safety studies to meet regulatory requirements across global markets. This interest is centered around visiting an animal facility conducting Good Laboratory Practice (GLP) animal safety studies that aim to meet regulatory requirements for both US and global markets. Discussion topics could include: GLP requirements in US and OECD countries, comparison of animal safety study requirements between US and other markets, how companies prioritize testing requirements when targeting both US and global markets, etc.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 A2

Combination Products

This area of interest is related to the integration of manufacturing and design of drug or biologic and device constituent parts of combination products.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 B1

Digital Health

Monitoring Artificial Intelligence System Performance

There is an interest in learning more about device monitoring, governing, and mitigation throughout the artificial intelligence/machine learning (AI/ML) lifecycle, in particular how companies are approaching system drift, local variability needs, performance specifications after deployment in various care settings (i.e., at home, health system, rural vs urban), and the collection and use of real-world data.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 C1

Cybersecurity Impact on Connected Care within Health Delivery Systems

There is an interest in learning more about medical device cybersecurity implementation and health equity challenges within a health system whose oversight spans urban, rural and critical access. We are interested in understanding the potential direct impacts to patient care during a cyber incident like a ransomware infection and the interoperability dependencies that may exist in the delivery practices which are impacted when technology becomes unavailable or disrupted. Risk mitigation and security tactics, in particular, when dealing with emerging technology such as medical devices that have AI/ML functionality or real-world data transfer to the cloud are elements to address.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 C2

Emerging Manufacturing Methods

We are interested in visiting health care settings that are engaged in 3D printing to support patient care, especially point of care settings and settings working under a quality management system. In particular, we hope to visit point of care sites that produce patient-matched devices, anatomical models for surgical planning, and other medical devices.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 D1

We are interested in visiting a company that either creates or extensively uses software to design patient-matched additively manufactured medical devices. In particular, we hope to learn about the level of human involvement in the process, process validation and control, and how other downstream software in the additive manufacturing ecosystem affects the patient matching process.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2025 D2

OCEA - Office of Clinical Evidence Analysis

Software as a Medical Device (SamD with AI/ML technology) with skin lesion analyzer and tumor tissue detection devices

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 E1

Academic or Clinical Research Organization (ACRO) clinical trial data collection - review of process from sponsor to where data comes from in a pivotal study

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 E2

OHT 1 - Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices

Complex Electromechanical Device Design

Design of complex electromechanical devices has become a sprawling process across electrical engineering, mechanical engineering, software firmware and cybersecurity engineering, usability engineering, and clinical utility. These devices have the added complication of integrated array of pneumatic sensors, regulators, and flow generators, and often operate in a system of other medical devices.

Training on the design process (or redesign process) of complex breathing gas machines (e.g., ventilators, CPAPs, anesthesia machines, nebulizers) and how the design process feeds towards the resulting design history file, risk management documents, verification validation activities, manufacturing, and service of these capital equipment medical devices is of interest.

We are interested in learning the design process used by companies to generate and manage the increasing complexity of these devices, from either a new device or an update to an existing device model.

  • Anticipated Participants: OHT 1
  • Identifier: 2025 F1

Bioelectronic Implants: Vision restoration, assessment techniques and human factors for patients with profound vision loss

We are interested in bioelectronic implants intended to restore vision in patients with profound vision loss (PVL). This includes devices such as brain and eye implants and means for measuring vision (visual function and/or functional vision) in patients with PVL.

  • Anticipated Participants: OHT 1
  • Identifier: 2025 F2

OHT 2 - Cardiovascular Devices

This area of interest is related to manufacturing of cardiovascular devices. Interest is centered around manufacturing processes, process validation, and manufacturing change assessment which may be related to reviews of IDE, PMA and 30-day notice submissions.

  • Anticipated Participants: OHT 2
  • Identifier: 2025 G1

This area of interest is related to observing and understanding how cardiovascular devices are used in clinical practice and in clinical trials.

  • Anticipated Participants: OHT 2
  • Identifier: 2025 G2

OHT 3 - Reproductive, Gastro‐Renal, Urological, General Hospital Device and Human Factors

We are interested in companies engaged in the development of new, innovative technologies in the renal space to better understand the process of bringing something new to the market and the challenges they face in their device development. We hope such an ELP visit would improve communication between FDA and these companies and would enable FDA to participate more fully in helping to get these devices ready for marketing. A special emphasis would be on implantable or wearable technologies, as well as scaled-down devices that will provide convenience and a better quality of life to patients.

  • Anticipated Participants: OHT 3
  • Identifier: 2025 H1

Design, development and manufacturing of large volume infusion pumps

  • Anticipated Participants: OHT 3
  • Identifier: 2025 H2

OHT 4 - Surgical and Infection Control Devices

Total Product Life Cycle for Personal Protection Equipment (PPE)

FDA has interest in learning about all phases of the Total Product Life Cycle (TPLC) as applied to PPE, from recognition of the market need, analysis of the potential technological methods to address the need and verify the performance (test methods), design of the product, design of the manufacturing process (including quality system), determining and addressing regulatory requirements, marketing of the device, handling complaints and addressing issues identified after the marketing, etc. Interest is particularly focused on the quality management processes used to ensure the products consistently provide the specified level of wearer protection.

  • Anticipated Participants: OHT 4
  • Identifier: 2025 I1

OHT 5 - Neurological and Physical Medicine Devices

Clinical observation of stereotactic neurosurgery procedures and research and development of neurological stereotactic systems.

  • Anticipated Participants: OHT 5
  • Identifier: 2025 J1

We are interested in visits related to all aspects of the total product life cycle for neurostimulation devices that have the potential for substantial public health impact on mental or physical impairments and in particular, in psychiatric, and neurological, and physical medicine conditions.

  • Anticipated Participants: OHT 5
  • Identifier: 2025 J2

OHT 6 - Orthopedic Devices

We are interested in the following: Visiting manufacturing and R&D testing facilities, observing surgical team(s) performing surgery in hospitals or ambulatory surgical centers, and understanding set up for cadaver-simulated testing labs for augmented reality devices.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 K1

We are interested in learning the complete process for patient-matched instruments and implants including manufacturing, R&D testing facilities, and software use. This includes when and how a surgical case is planned, how the patient images are acquired, and quality is controlled, what software and interfaces are utilized, and how the guides are created, verified by surgeons, manufactured, tested, and used in the surgery.

  • Anticipated Participants: OHT 6
  • Identifier: 2025 K2

OHT 7 - In Vitro Diagnostics

Design and manufacturing of innovative laboratory-based tests and integration of diagnostic data

Design and manufacturing of innovative laboratory-based tests including chemistry, toxicology, urinalysis and cardio-renal devices, biomarkers for ALS, Alzheimer's Disease and Traumatic Brain Injury, clinical laboratory hematology tests, and a variety of adeno-associated virus gene therapy assays, as well as innovation such as AI digital pathology capable of interpreting the mutation status of tissues by imaging and personalized Molecular Residual Disease (MDR) technologies that tailor the test to the specific patient mutations and profiles. This also includes opportunities and challenges laboratories and IVD developers face in coding, harmonizing, and transmitting diagnostic data among and between institutions (e.g., hospitals, pharmacies, clinics, public health agencies).

  • Anticipated Participants: OHT 7
  • Identifier: 2025 L1

Special Considerations for Point-Of-Care and Home Use Devices

Point-of-Care (POC) and home use in vitro diagnostic tests, including new development as well as challenges in obtaining coverage and reimbursement for new devices. This also includes design opportunities and challenges, validation approaches using conventional and real-world data studies, and digitization or diagnostic workflows (e.g., mobile apps, digital readers, data capture and transmission to healthcare providers)

  • Anticipated Participants: OHT 7
  • Identifier: 2025 L2

OHT 8 - Radiological Health

Adaptive Radiation Therapy

The use of adaptive radiation therapy techniques has evolved over the past few years, with an increase in software devices that allow for changes to the radiation therapy plan while the patient is on the table. Although offline adaptive planning has been long practiced, making changes to the radiation therapy plan while the patient is awaiting treatment (i.e., "on-table" or "online" adaptive planning) introduces possible new concerns, such as: the algorithms used to generate the new plans, the length of time needed for the changes to be implemented, and the process for validating the changes. In addition to learning how these potential concerns are addressed, it would be beneficial to learn about best practices from clinics actively implementing online adaptive planning and whether there are any limitations on specific patient populations and intended users. Lastly, if there are any future plans to implement "real-time" adaptive radiation therapy planning, where changes to the treatment plan are automated by the machine and software, it would be beneficial to learn about these as well.

  • Anticipated Participants: OHT 8
  • Identifier: 2025 M1

Photon-Counting Computed Tomography (CT)

Photon-counting CT is a technique that involves the counting of individual photons from X-ray sources. This method is different from conventional CT systems that use energy-integrating detectors, which measure the total X-ray energy reaching the detector. Photon-counting CT systems can effectively filter out electronic noise, potentially leading to a significantly improved signal-to-noise ratio. The spectral information from photon counting can be used to characterize certain incidental findings.  We are interested in a virtual or in-person visit to a clinic that currently utilizes a photon-counting CT system in their clinical practice to learn more about the essential clinical applications that a photon counting CT is applied to and can be applied to in the future.

  • Anticipated Participants: OHT 8
  • Identifier: 2025 M2

ORP - Office of Regulatory Programs

Unique Device Identifiers (UDI) implementation in healthcare

We are interested in the process of UDI implementation in healthcare facilities. Specifically, the workflow of UDI in medical 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. We prefer an in-person site visit, if possible.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 N1

Reprocessing and Sterilization

Considerations for different sterilization methods, including alternatives to ethylene oxide

FDA has an interest in learning about different sterilization methods for use in terminal sterilization of medical devices (including alternatives to ethylene oxide), including understanding more about considerations for cycle design, validation, and the applicability of different sterilization methods across a broad spectrum of medical devices. Interest is particularly focused on the considerations necessary to adopt a specific sterilization method or to change from one method to another.

  • Anticipated Participants: Cross Cutting
  • Identifier: 2025 O1

ELP Participation Structure Key

  • Biocompatibility
  • Combination Products
  • Digital Health
  • Emerging Manufacturing Methods
  • OCEA - Office of Clinical Evidence Analysis
  • OHT 1 - Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
  • OHT 2 - Cardiovascular Devices
  • OHT 3 - Reproductive, Gastro‐Renal, Urological, General Hospital Device, and Human Factors
  • OHT 4 - Surgical and Infection Control Devices
  • OHT 5 - Neurological and Physical Medicine Devices
  • OHT 6 - Orthopedic Devices
  • OHT 7 - In Vitro Diagnostics
  • OHT 8 - Radiological Health
  • OCEA - Office of Clinical Evidence and Analysis
  • ORP - Office of Regulatory Programs
  • Regulatory Science Tools
  • Reprocessing and Sterilization
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