title: Safety and effectiveness considerations for clinical studies of visual prosthetic devices.
abstract: With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.
authors.affiliation: Division of Physics, Office of Science and Engineering Labs, Center for Devices and Radiological Health, HFZ130, 12725 Twinbrook Pkwy., Rockville, MD 20852, USA. ethan.cohen@fda.hhs.gov
authors.forename: Ethan D
authors.initials: ED
authors.lastname: Cohen
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D018795:Device Approval / Q000592:standards*; D004867:Equipment Design / Q000592:standards; D019544:Equipment Failure Analysis / Q000592:standards; D004869:Equipment Safety / Q000592:standards*; D017408:Guidelines as Topic; D019736:Prostheses and Implants / Q000592:standards*; D017751:Safety Management; D014481:United States; D014786:Vision Disorders / Q000534:rehabilitation*