The following table provides the Spring 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 Spring 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 checking the "Patient Engagement Relevant" box in the Site Visit Request Sample.

On this page:

• 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
• ORP - Office of Regulatory Programs
• Regulatory Science Tools
• Reprocessing and Sterilization

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Biocompatibility

Solutions for Challenging Animal Models

We are seeking opportunities to better understand creative approaches companies are using to mitigate challenges associated with animal safety studies of Class III medical devices, including but not limited to alternative animal models, cadaver models, simulated use models, and virtual reality approaches.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 A1

Good Laboratory Practice Animal Studies

This area of interest is centered around touring an animal facility that regularly conducts studies of medical devices that are complaint with Good Laboratory Practice (GLP) to learn about the conduct of these studies, to observe a surgical or interventional procedure in a large animal model (to better

• Anticipated Participants: Cross Cutting
• Identifier: 2024 A2

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Combination Products

Drug-Eluting Stents (Cardiovascular, Neurology, or Other)

We are interested in learning more about the design and manufacturing of drug- coated or drug-eluting stents. Processes of interest include the manufacturing of the stent, performance testing of stents, the drug coating process, and drug stability testing. Additional topics that could be discussed include risk analysis considerations and the processes used to determine the type of testing needed in the design or manufacturing phases of Combination product development.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 B1

Drug Delivery Devices (Autoinjectors, On-Body Delivery Devices, or Other)

We are interested in learning more about the design and manufacturing of drug delivery devices. Processes of interest include the manufacturing of the delivery devices, the performance testing of delivery devices, the drug filling process, drug stability testing, supplier controls, and supplier management. Additional topics that could be helpful for discussion include risk analysis considerations, and processes used to determine the type of testing needed in the design or manufacturing phases of combination product development.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 B2

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Digital Health

Predictive and Generative AI Model System Performance

We are interested in learning more about postmarket activities, especially those using real-world evidence, at medical device establishments with FDA-cleared or approved predictive and generative artificial intelligence (AI) systems. We are interested in how companies determine how and when these systems are deployed, and how companies track drift of the systems. We are also interested in how they assess whether changes are needed to address local variability and how such changes are implemented. Lastly, we are interested in how companies track performance specifications after the system has been deployed in different settings (e.g., rural, urban settings), and how companies obtain real-world data to support premarket submissions to support expanding an intended use.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 C1

Connected Care Digital Health Technologies in a Home Setting; Home Use Digital Health Technologies

We are interested in visiting sites that manufacture augmented at-home tests and point-of-care in vitro diagnostic devices. We are interested in manufacturing and large academic health systems sites to learn more about digital health technologies and diagnostics for use in non-clinical care settings, such as the home. In addition, we hope to learn more about how digital health technologies may help foster remote clinical trials, data transmission from these devices to a care provider (clinic, center, or hospital), integration with electronic health records, evidence generation, and data analysis methods from the data provided by a patient or from a device.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 C2

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Emerging Manufacturing Methods

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. 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: 2024 D1

Additive Manufacturing of Medical Implants

We are interested in observing additive manufacturing (AM) systems operating in a traditional manufacturing setting — at a medical device original equipment or contract manufacturer. We hope to learn more about how additive manufacturing practices have evolved and observe the latest generation of laser powder bed fusion thermography. We are interested in post-processing practices and the software workflow to support this process. We are especially interested in observing an in-person, multi-laser capable AM system that has the capability to vary build-layer thickness within a part.

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

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OCEA - Office of Clinical Evidence Analysis

Academic clinical research site or Clinical Research Organization (CRO)

We hope to observe processes that highlight how statisticians collaborate with clinicians and other colleagues:

• In developing the study protocol and Case Report Form (CRF) at the clinical study design stage
• How they ensure the study is conducted in alignment with the protocol and data is appropriately collected at the study conduct stage, and how they ensure the study integrity (masked data) is protected in the interim analysis
• How they clean and analyze the data after the dataset is locked

In addition, we are interested in better understanding processes related to site selection, study start-up, creation of data collection forms (with data checks), enrollment and data curation. We are also hoping to see methods of integrating traditional clinical trial data from electronic health records into traditional methods of clinical trial management or into decentralized clinical trials.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 E1

Signal Detection Using Real-World Data

We are seeking opportunities to visit sites that use real-world data source identification for safety signals. These sites may be at a hospital, study sponsor, manufacturer, or at a site involved in the creation, maintenance, or use of device patient registries for research purposes.

• Anticipated Participants: Cross Cutting (potentially including multiple offices within CDRH)
• Identifier: 2024 E2

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

Design Controls and Process Validation - Flow-generating Ventilation Systems

We are interested in the quality system and design controls applicable to different types of flow generators, along with the design and design validation of pneumatic systems for flow-generating ventilation systems (ventilators).

• Anticipated Participants: OHT 1
• Identifier: 2024 F1

The Total Product Life Cycle for Intraocular Lenses

We hope to discuss and observe on-site demonstrations related to research and development, approaches to developing the intended use (including intended populations), manufacturing, and complaint handling for intraocular lenses.

• Anticipated Participants: OHT 1
• Identifier: 2024 F2

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OHT 2 - Cardiovascular Devices

Manufacturing of Complex Transcatheter Cardiovascular Implants

Our area of interest is related to manufacturing of complex transcatheter cardiovascular implant devices. Examples include but are not limited to: Heart valves and valve repair devices, cardiac occluders, and endovascular grafts. Interest is centered around manufacturing processes, process validation, and manufacturing change assessment that may be related to reviews of complex Investigational Device Exemption applications, Premarket Approval Applications, and 30-day Notices for these devices.

• Anticipated Participants: OHT 2
• Identifier: 2024 G1

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

Manufacturing and Testing of Urinary Catheters

We are interested in observing how urinary catheters are manufactured and the non-clinical testing conducted for these devices.

• Anticipated Participants: OHT 3
• Identifier: 2024 H1

Infusion Pumps

Design, development, and manufacturing of large volume infusion pumps.

• Anticipated Participants: OHT 3
• Identifier: 2024 H2

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OHT 4 - Surgical and Infection Control Devices

General and Plastic Surgery Devices Including Breast Implants, Dermal Fillers, Wound Care and Aesthetic Medical Devices

We seek opportunities to gain knowledge and insight into all areas of the Total Product Life Cycle for general and plastic surgery devices, including breast implants, dermal fillers, wound care, and aesthetic medical devices. We are interested in:

• Quality management systems
• Research and development, including assessment of initial concept, device design, animal and human factors studies and assessment of customer needs and previous product experience
• Procedures related to building prototypes, performing failure mode effects analysis, developing, and conducting non-clinical testing including simulations, bench testing
• Procedures related to evaluating anomalies found during testing and use and deciding whether to redesign or retest a device
• Use of quality manufacturing processes (including statistical methods, and controls), supporting continuous process feedback into the manufacturing processes
• Evaluation of complaints and returned products to identify trends and assess product quality
• Development and continuous improvement of instructions for use
• Manufacturing and postmarket activities

• Anticipated Participants: OHT 4
• Identifier: 2024 I1

Clinician and Patient Perspectives Regarding the Use of Plastic Surgery, Dermatology, and General Surgery Devices

We request opportunities to hear clinician, patient, and caregiver perspectives regarding the use of aesthetic devices, such as general or plastic surgery and dermatology devices, including barbed sutures, dermal fillers, and microneedling devices. The scope of these discussions could include perceived benefits, limitations, and constraints experienced by patients, caregivers, and clinicians.

• Anticipated Participants: OHT 4
• Identifier: 2024 I2

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OHT 5 - Neurological and Physical Medicine Devices

Neurological Stereotactic Navigation Systems

We are interested in observing stereotactic neurosurgery procedures, and opportunities to learn more about research and development of neurological stereotactic systems.

• Anticipated Participants: OHT 5
• Identifier: 2024 J1

Deep Brain Stimulation

We are interested in clinical uses of deep brain stimulation devices for neurological, psychiatric, and physical medicine purposes.

• Anticipated Participants: OHT 5
• Identifier: 2024 J2

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OHT 6 - Orthopedic Devices

Orthopedics

Our interest is in understanding the scientific processes for generating high quality real-world evidence (RWE), leveraging various real-world data (RWD), and understanding how RWE can be used to support the evaluation of the safety and effectiveness for orthopedic medical devices and inform regulatory decisions.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 K1

Human Factors, Usability and Performance Testing of Orthopedic Devices

We would like to visit surgeons' training facilities, device validation and/or cadaver testing facilities, and sites conducting simulated use testing.

• Anticipated Participants: OHT 6
• Identifier: 2024 K2

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OHT 7 - In Vitro Diagnostics

Sites Focused on Research and Development, Clinical Trials, and Public Health Issues Related to Novel Technologies for In Vitro Diagnostics

We are interested in visiting highly automated clinical labs or manufacturers involved with the use or development of novel laboratory technologies related to companion diagnostics, machine learning, artificial intelligence-based diagnostic devices, immunohistochemistry reagents, first-of-a-kind in development for neurological conditions such as amyotrophic lateral sclerosis and Alzheimer's disease, or digital pathology devices that are commonly used in pathology laboratories.

• Anticipated Participants: OHT 7
• Identifier: 2024 L1

Manufacturing, Quality Systems, and Postmarket Oversight of Augmented At-Home Tests and Point-of-Care In Vitro Diagnostic Devices

We are interested in visiting sites that manufacture at-home tests and point-of-care in vitro diagnostic devices.

• Anticipated Participants: OHT 7
• Identifier: 2024 L2

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OHT 8 - Radiological Health

Virtual and Augmented Reality in Interventional Procedures

We are interested in Augmented Reality/Virtual Reality (AR/VR) Head-Mounted Displays (HMDs) that are used to overlay digital information onto the physical world or incorporate aspects of the physical world into virtual scenes. Examples of AR/VR technologies include AR/VR used in planning and navigation for endovascular aortic aneurysm repair, and AR HMD used to superimpose a surgical anatomy from computed tomography angiography onto the patient's body for preoperative planning to guide trocar placement and dissection.

• Anticipated Participants: OHT 8
• Identifier: 2024 M1

Point-of-Care Ultrasound: Clinical practices for Ultrasound Imaging Using Percutaneous Procedures, and Reprocessing of Probes Used in these Procedures at Point-of-Care and Industrial Reprocessing Sites

We are interested in observing current ultrasound imaging practices that utilize recent developments in these ultrasound technologies. Specifically, we are interested in approaches to cleaning and disinfecting ultrasound probes that have been used in percutaneous procedures at industrial reprocessing sites and at on-site reprocessing sites. We are also interested in observing the use of ultrasound probes in percutaneous procedures and subsequent point-of-care reprocessing procedures.

• Anticipated Participants: OHT 8
• Identifier: 2024 M2

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ORP - Office of Regulatory Programs

Unique Device Identifier (UDI) Implementation in Health Care

We are interested in the process of unique device identifier (UDI) implementation in health care facilities. Specifically, the workflow of UDI in medical facilities' supply chain (purchasing, inventory management, through patient use), its support for their return on investment (ROI), and how UDIs is being utilized for medical device recalls and adverse events once UDI systems are in place.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 N1

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Regulatory Science Tools

Cardiac Electrophysiology Medical Devices

We hope to learn about pre-clinical approaches adopted by medical device developers to better target regulatory science tools. Specific areas of interest include pre-clinical testing of cardiac contractility modulation implantable devices that deliver non-excitatory pulses to improve heart contractility and pulsed field ablation devices for atrial fibrillation treatment.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 O1

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Reprocessing and Sterilization

Reprocessing and Sterilization

We are interested in the reprocessing of single-use medical devices.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 P1

Reprocessing and Sterilization

We are interested in the reprocessing of single-use devices, and the impact that they are having on public health and in the marketplace. We are also interested in understanding the impact that reprocessed, single-use devices are having in the health care industry and its impact on public health. We are seeking to understand the efforts that third-party companies take to reprocess a single-use device and bring it back to the original equipment manufacturer's (OEM) specifications.

• Anticipated Participants: Cross Cutting
• Identifier: 2024 P2

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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
• Cross Cutting - Potentially including multiple offices within CDRH