- Devices Appropriate for Early Feasibility Studies
- Early Feasibility Studies Submission and Review Process
- EFS Contacts
An early feasibility study (EFS) is a limited clinical investigation of a device early in development. It typically:
- enrolls a small number of subjects;
- is used to evaluate the device design concept with respect to initial clinical safety and device functionality; and
- may guide device modifications.
CDRH's EFS Program facilitates the conduct of early feasibility studies in the United States to increase access for patients to potentially beneficial technologies and to support device innovation. EFS concepts are described in the FDA guidance document, Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical studies, Including Certain First in Human (FIH) Studies.
The EFS Program provides a mechanism for innovators to work directly with, sponsors, FDA review teams, and clinicians to work together early so they can increase the efficiency of their device development. Early clinical experience obtained from an EFS can provide insights for sponsors and FDA review teams into device proof of concept, patient characteristics that may impact performance, operator technique refinements, device safety, necessary device modifications, and human factors.
Components of the EFS Program include:
- Opportunities for interactive review
- Assistance in submission preparation from an EFS Program representative
- Potential for less non-clinical data to support study initiation relative to the data needed for larger clinical studies based on use of clinical mitigation strategies
- New mechanisms for timely device and clinical protocol modifications
The EFS Program is open to devices subject to Premarket Approval (PMA), Premarket Notification (510[k]), De Novo classification, or Humanitarian Device Exemption (HDE). EFS may be applicable when clinical experience is necessary because non-clinical testing is unavailable or inadequate to provide the information needed to advance device development. Therefore, EFS may be conducted on new devices without prior clinical experience and in some cases, may also be conducted on devices with limited prior clinical experience. For example devices previously used under the Expanded Access pathway, devices used outside of the United States, or marketed devices being proposed for a new indication are suitable for investigation in an EFS.
Medical device developers interested in conducting an EFS should:
- Contact an EFS Program representative to discuss the program and to receive assistance in preparing an EFS submission.
- Submit a Pre-Submission that describes the device concept, clinical context, and rationale for performing an EFS prior to submitting the IDE itself. Please note, an important goal of a Pre-Submission is to reach consensus with the FDA review team on the information needed to support study initiation based on a risk analysis, non-clinical testing, and clinical risk mitigation strategies.
- Engage with CDRH to request feedback on specific non-clinical testing protocols or details of the investigational plan through additional pre-submission supplements if necessary.
- Submit an IDE request to initiate the EFS.
For additional information about the EFS or assistance on preparing a submission, please e-mail the appropriate device review division listed below:
|CDRH Review Group||Email Address|
|OHT1: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices||OHT1_EFS@fda.hhs.gov|
|OHT2: Cardiovascular Devices||OHT2_EFS@fda.hhs.gov|
|OHT3: Reproductive, Gastro-Renal, Urological, General Hospital Devices and Human Factors||OHT3_EFS@fda.hhs.gov|
|OHT4: Surgical and Infection Control Devices||OHT4_EFS@fda.hhs.gov|
|OHT5: Neurological and Physical Medicine Devices||OHT5_EFS@fda.hhs.gov|
|OHT6: Orthopedic Devices||OHT6_EFS@fda.hhs.gov|
|OHT7: In Vitro Diagnostics and Radiological Health||OHT7_EFS@fda.hhs.gov|
For general information regarding the EFS Program, please contact CDRH_EFS@fda.hhs.gov.
- Guidance: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical studies, Including Certain First in Human (FIH) Studies
- Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
- Draft Guidance: Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus
- Breakthrough Devices Program webpage
- CDRH Learn Modules: How to Study and Market Your Device: Clinical Studies/IDE