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  1. FDA STEM Outreach, Education and Engagement

Experiential Learning Program (ELP) Areas of Interest

The following table provides the Fall FY 2024 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 2024 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 indicating this when completing the Site Visit Request (for example, Site Visit Request Sample).

On this page:

Combination Products

Innovative Combination Product Design for Dermal, Transdermal, or Ocular Drug Delivery

We are interested in learning about how industry comes up with innovative designs in combination products for dermal, transdermal or ocular drug delivery. Particular focus should be in Design Facilities involved in designing device/drug or device/biologic combination products with an emphasis on design controls involved to meet the Quality System requirements and GMP requirements for the finished combination product with a deeper dive in risk analysis, design verification testing, and design validation testing.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 A1

Combination Product Design Innovations in the Dental and Orthopedic Space

We are interested in learning about how industry comes up with innovative designs in combination products in the dental and orthopedic space. Particular focus should be in Design Facilities involved in designing device/drug or device/biologic combination products with an emphasis on design controls involved to meet the Quality System requirements and GMP requirements for the finished combination product with a deeper dive in risk analysis, design verification testing, and design validation testing.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 A2

Digital Health

Innovation in Connected Health at Home

There is a need for seamless integration of digital health technologies into the delivery of healthcare outside the four walls of a hospital and into the home. Unique technology considerations for achieving this goal include interoperability, data analytics, usability, and equitable access. A better understanding of how developers and healthcare organizations develop and implement these solutions in a patient-centric, equitable, and integrated manner will expedite the benefits of these approaches for patients.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 B1

Novel Clinical Application of Medical Extended Reality (MXR)

Innovation in Medical Extended Reality (MXR) Devices has been supported by advances in computing and display technology, including low-cost mixed-reality products, for augmented reality (AR) and virtual reality (VR). These technologies have been applied to chronic disease management including for drug rehabilitation, smoking cessation, behavioral health, asthma, and diabetes. A better understanding of novel MXR technology-enabled care, with a focus on specific high impact clinical use cases for drug rehabilitation and diabetes, is important to support the evaluation and adoption of these products.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 B2

Innovation / Health Technology Assessment / Market Access

Medical Device Innovation by Small Businesses and Start-Ups

Innovators that develop and manufacture leading-edge medical devices frequently are small start-up companies, small businesses, and non-traditional medical device innovators (for example, students, nurses, caregivers, patients). Understanding the unique needs of these innovators will help CDRH staff better assist them during the review process. For this training, please include a shadowing/matching component with the start-up companies in your incubator/accelerator so each participant can meet 1:1 with a start up to learn directly from them the unique regulatory challenges faced.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 C1

Promoting Innovation in the Medical Device Ecosystem: Consideration of non-FDA stakeholders

Patient access to novel, safe and effective medical devices – the primary mission of CDRH –usually requires more than regulatory approval or clearance. For most devices, patient access requires approval or buy-in of others in the medical device ecosystem, such as payors and professional societies. Often the evidence needed by others to support their decision is different from the market authorization requirements. This training should present to CDRH staff information on the non-FDA stakeholders and how innovators interact with them and plan for their needs.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 C2

OCEA - Office of Clinical Evidence Analysis

Software As A Medical Device and AI/ML in Diagnostic Devices

AI/ML based software devices; and challenges in development and validation of AI/ML-based diagnostic devices.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 D1

Applications of Next Generation Sequencing (NGS), Immunohistochemistry (IHC), and Artificial Intelligence/Machine Learning (AI/ML) Technology in the MCED Device Development Process

Multi-cancer Early Detection (MCED) Tests and NGS based tests (CDx, ctDNA, MCED): Interest in development, validation, and modification of MCED tests; analytical validation, procurement of samples, types of processing, bioinformatics pipeline, clinical studies/clinical validation, quality systems, central laboratories vs Point-of-care devices.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 D2

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

Total Product Life Cycle for the Development and Marketing of Intraocular Lenses

A few companies have the ability to provide insight in the Total Product Life Cycle (TPLC) of Intraocular lenses (IOLs). Specifically, we hope to attend on-site demonstrations that include open discussions about the research and development, marketing approaches, and manufacturing of these devices.

  • Anticipated Participants: OHT 1
  • Identifier: 2024 E1

OHT 2 - Cardiovascular Devices

Peripheral Stent and Delivery System Manufacturing

Manufacturing of metallic, absorbable, and drug-coated stents and their associated delivery systems. Interest is centered around the general manufacturing processes and validation activities related to reviews of complex IDE, PMA, and 30-day notice submissions. Staff are interested specific complex manufacturing activities, such as laser cutting, electropolishing, coating, crimping, batch, and stability testing. Additionally, determining appropriate sampling schemes for in-process validation and batch testing would be beneficial.

  • Anticipated Participants: OHT 2
  • Identifier: 2024 F1

FDA Good Laboratory Practice - Animal Studies

Good Laboratory Practice (GLP) animal studies are a critical component of premarket reviews. We hope to tour animal facilities that regularly perform animal studies of medical devices that are compliant with FDA GLP requirements to observe the conduct of animal studies, attend a surgical or interventional procedure in a large animal model (to better understand the personnel, equipment, monitoring, and animal model limitations), and to observe a necropsy evaluation while discussing the importance of the pathology analysis in animal studies.

  • Anticipated Participants: OHT 2
  • Identifier: 2024 F2

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

Software As a Medical Device/Interoperability

Design and development of software as a medical device (SaMD), including standalone software as well as software intended to exchange and use information among one or more medical devices.

  • Anticipated Participants: OHT 3
  • Identifier: 2024 G1

OB/Gyn Device Innovation

The development of novel, innovative devices in women's health is important to the FDA's mission to protect and promote public health. Innovators that develop and manufacture leading-edge medical devices frequently are small start-up companies, small businesses, and non-traditional medical device innovators (for example, students, nurses, caregivers, patients). Understanding the unique needs of these innovators may help CDRH staff better appreciate challenges encountered during the review process.

  • Anticipated Participants: OHT 3
  • Identifier: 2024 G2

OHT 4 - Surgical & Infection Control Devices

Thermal Tissue Ablation

Numerous medical treatments and surgical procedures require thermal tissue ablation, using radiofrequency, microwave, laser, cryogenic, and/or other technologies. The specific learning goal or focus encompasses the entire ablation process, from patient treatment planning methods (imaging, computational models, etc.), performing thermal therapy (surgical methods/technique), through post-procedure verification of the intended ablation.

  • Anticipated Participants: OHT 4
  • Identifier: 2024 H1

In Vitro and In Vivo Testing for Biocompatibility

OHT4 requests training opportunities to gain knowledge and a better understanding and insight into in vitro and in vivo testing used to demonstrate biocompatibility of medical devices in contact with breached or compromised skin, as well as implanted devices (permanent contact). Discussion about how third-party test labs engage with sponsors to ensure that testing aligns with overall regulatory strategy, including how decisions are made about test protocols, sample preparation, test methods, data collection, analysis and conclusions.

  • Anticipated Participants: OHT 4
  • Identifier: 2024 H2

OHT 5 - Neurological & Physical Medicine Devices

VR / Augmented Reality Devices

Particular interest in Virtual Reality / Augmented Reality devices indicated for use in neurological applications, such as in the aid in the diagnosis or treatment/procedure of neurological diseases or conditions emphasizing on clinical testing.

  • Anticipated Participants: OHT 5
  • Identifier: 2024 I1

Prosthetics / Neuromodulation Medical Devices

Prosthetics development is a rapidly advancing area that can potentially serve both civilian and military service personnel patient populations where amputee and spinal cord injury represents broad US public health challenges. Neurostimulation devices have the potential for substantial public health impact on mental or physical impairments because of the high incidence in psychiatric and neurological conditions. Several types of submissions in the prosthetic and neuromodulation sector to be discussed include pre-submissions, 510(k), de novo, and PMA.

  • Anticipated Participants: OHT 5
  • Identifier: 2024 I2

OHT 6 - Orthopedic Devices

Incorporation of Antimicrobial Activity into Orthopedic Implants to Prevent or Treat New or Recurring Infections

Antimicrobial functionality and capability have been incorporated in various implanted orthopedic devices and products in efforts to prevent or treat new or recurring infections through a variety of strategies including the incorporation of bulk- or surface-eluting antimicrobial agents, application of coatings to orthopedic implants, and surface modifications of orthopedic implants.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 J1

Shoulder Device Specific Manufacturing and Testing Facilities

Interest is centered around visits specifically to shoulder device companies to gain knowledge on research and product development, various non-clinical testing, and manufacturing processes including additive manufacturing.

  • Anticipated Participants: OHT 6
  • Identifier: 2024 J2

OHT 7 - In Vitro Diagnostics

Manufacturing, Quality Systems, and Post-market Considerations

IVD reagent and finished device manufacturing and quality systems: In view of the risks presented by In Vitro Diagnostic (IVD) medical device recalls, the FDA is continually working in collaboration with industry to identify manufacturing process risks when changes are introduced for PMA devices to help prevent product recalls from occurring. The FDA also reviews the corrective actions associated with IVD product recalls to ensure that firms are implementing adequate actions to prevent recurrence of the product issues. As many IVD recalls can be attributed to issues in manufacturing or a firm's quality systems, understanding of large-scale manufacturing and risks that can potentially be introduced is critical for review of PMA change supplements and product recalls. Adequate Process Validation of all aspects of IVD manufacturing is critical to ensuring and maintaining product quality.

  • Anticipated Participants: OHT 7
  • Identifier: 2024 K1

Diabetes Care Devices with Focus on Clinical Trial Experiences or Research & Development

Diabetes clinical trial sites: Interest is focused on research centers dedicated to executing clinical trials for future treatments to cure diabetes and related health conditions.

  • Anticipated Participants: OHT 7
  • Identifier: 2024 K2

OHT 8 - Radiological Health

Diagnostic X-ray Systems

Clinical Use of Fluoroscopic Imaging or Corresponding Stereotactic Device- Fluoroscopic imaging can be used during interventional procedures. The risks associated with the use of fluoroscopic imaging (or the corresponding stereotactic devices) are higher than other X-ray imaging modalities. A complete understanding of the potential risks, and thorough understanding of the related clinical workflows, aids review of these devices. Therefore, interest is focused on visiting academic or hospital-related sites that target specific fluoroscopic imaging-based interventional procedures.

  • Anticipated Participants: OHT 8
  • Identifier: 2024 L1

Use of Artificial Intelligence/Machine Learning in Radiology

To help analyze images for a patient's diagnosis, there are numerous software devices that use artificial intelligence/machine learning (AI/ML) in the radiology workflow. Since the use of AI/ML-enabled software devices is rapidly evolving, it is essential to understand patient workflows and the roles of the radiologic imaging software devices. As a result, there is interest in visiting academic or hospital-related sites that use AI/ML radiology software devices for patient management. There is specific interest in clinical sites that use AI/ML devices with live cases included (for example, catheterization laboratories and the interventional radiology suite). There is also interest in sites that use software devices based on AI/ML algorithms that aid the radiology workflow by helping to automatically locate, identify, or triage images. In addition, the Agency is interested in understanding whether clinical sites validate the output of AI/ML software devices to assess the applicability and usability of that software for a specific site.

  • Anticipated Participants: OHT 8
  • Identifier: 2024 L2

ORP - Office of Regulatory Programs

Online Market Place (OMP) Evaluation of Sellers and Products Subject to the FDA's Oversight

We are interested in understanding how OMPs assure online sellers and products sold online are compliant with the FDA's regulations that are intended to assure medical devices are safe, effective, and authorized for sale to consumers.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 M1

Regulatory Science Tools

Preclinical Hemodynamics and Durability Testing of Cardiovascular Medical Devices

Areas of interest include preclinical benchtop testing of cardiovascular devices, specifically interest in testing related to hemodynamics and durability.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 N1

Therapeutic Ultrasound for Neurological Applications

Specific areas of interest include neuromodulation and overcoming the blood-brain-barrier using ultrasound-based technologies. Interested in bench, animal, and clinical testing of these devices for neurological applications across all patient populations. We also welcome learning experiences that focus on high-risk, vulnerable, pediatric, or neonatal populations.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 N2

Reprocessing and Sterilization

Personal Protective Equipment: Supply and Reprocessing of Reusable Personal Protective Equipment

The COVID-19 pandemic caused shortages of personal protective equipment (PPE). Although the PPE shortages are mostly resolved, we anticipate that the demand for PPE will continue. Most of the current, FDA-cleared or approved PPE for healthcare use are single use, disposable devices. Some device manufacturers and others are also developing and evaluating reusable PPE that can be used in healthcare settings. We are interested in furthering our understanding of reprocessing of reusable PPE, including various types of cleaning agents and disinfectants, sterilization techniques, and methods for assessing effectiveness. Other areas of interest include the assessment of log reduction of bioburden and material compatibility, the validation of instructions for cleaning and disinfection or cleaning and sterilization of devices, and monitoring reprocessing procedures.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 O1

Sterilization and Reprocessing of Sterilization Wraps and Trays

We are interested in furthering our understanding of the overall validation of sterilization wraps and trays, including how the determination of most resistant microorganisms for biological indicators and chemistry of chemical indicators is made, modality-specific considerations, and validation strategies. Specifically, we are interested in any of the various sterilization methods whether they are commonly used or are used less frequently.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 O2

Standards and Conformity Assessment

Conformity Assessment of Consensus Standards

Visit a Testing Laboratory Educating CDRH staff on the practical aspects of how testing laboratories operate and evaluate medical devices to enhance understanding of what goes into a test report provided in a premarket submission. Topics of interest include: general testing processes and equipment used in a typical testing laboratory for medical devices; what ISO/IEC 17025 accreditation means and how testing laboratories are accredited to ISO/IEC 17025; testing using consensus standards with clear acceptance criteria vs those without acceptance criteria; visiting a testing laboratory accredited through the FDA's Accreditation Scheme for Conformity Assessment (ASCA) covering practical aspects of participation in the ASCA Program and also visiting non-ASCA laboratories; and translation of testing into a test report that can be used to support a declaration of conformity in a premarket submission.

  • Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
  • Identifier: 2024 P1

 

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