FDA Standards

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The FDA is responsible for many things. As regards medical equipment, its direct responsibility stops at the manufacturer.
Document issued: July 22, 2002, current as of June, 2003.
  • Identify the applicable recognized consensus standards that were met;
     
  • Specify, for each consensus standard, that all requirements were met, except for inapplicable requirements or deviations noted below;
     
  • Identify, for each consensus standard, any way(s) in which the standard may have been adapted for application to the device under review, e.g., identify which of an alternative series of tests were performed;
     
  • Identify, for each consensus standard, any requirements that were not applicable to the device;
     
  • Specify any deviations from each applicable standard that were applied (e.g., deviations from international standards that are necessary to meet U.S. infrastructure conventions such as the National Electrical Code (ANSI/NFPA 70).
     
  • Specify what differences exist, if any, between the tested device and the device to be marketed and justify the use of test results in these areas of difference; and
     
  • If a test laboratory or certification body was employed, provide the name and address of each laboratory or certification body that was involved in determining the conformance of the device with the applicable consensus standards and a reference to any accreditations of those organizations.