title: Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States.
abstract: Initial clinical studies of new medical technologies involve a complex balance of research participant benefits versus risks and costs of uncertainty when novel concepts are tested. The Food and Drug Administration Center for Devices and Radiological Health has recently introduced the Early Feasibility Study (EFS) Program for facilitating the conduct of these studies under the Investigational Device Exemption regulations. However, a systematic approach is needed to successfully implement this program while affording appropriate preservation of the rights and interests of patients. For this to succeed, a holistic reform of the clinical studies ecosystem for performing early-stage clinical research in the United States is necessary. The authors review the current landscape of the U.S. EFS and make recommendations for developing an efficient EFS process to meet the goal of improving access to early-stage, potentially beneficial medical devices in the United States.
authors.affiliation: Department of Cardiology, Mayo Clinic, Rochester, Minnesota. Electronic address: holmes.david@mayo.edu.
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
authors.affiliation: Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Robert
authors.initials: R
authors.lastname: Califf
authors.affiliation: Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Andrew
authors.initials: A
authors.lastname: Farb
authors.affiliation: Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Dorothy
authors.initials: D
authors.lastname: Abel
authors.affiliation: Baylor Scott and White Health, Plano, Texas.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Centers for Medicare & Medicaid Services, Baltimore, Maryland.
authors.forename: Tamara
authors.initials: T
authors.lastname: Syrek Jensen
authors.affiliation: Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Bram
authors.initials: B
authors.lastname: Zuckerman
authors.affiliation: Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, New York.
authors.forename: Martin
authors.initials: M
authors.lastname: Leon
authors.affiliation: Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Jeff
authors.initials: J
authors.lastname: Shuren
mesh_terms: D035843:Biomedical Research / Q000379:methods / Q000592:standards; D004864:Equipment and Supplies; D005240:Feasibility Studies; D017408:Guidelines as Topic; D014481:United States
keywords: United States Food and Drug Administration; equipment design; new device development strategies; research design; research ethics committees