FDA BRIEF: Week of July 11, 2016

fda guidances



  • Electrically-powered devices: AC (mains) powered devices, battery powered devices, and active implantable devices
  • EMC: Ability of device to function safely and effectively in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference), without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices.
  • Relevant information for PMA/510(k)/HDE/De Novo

Relevant Information:

  • Environments
  • Testing summary
  • Specifications
  • Pass/Fail criteria
  • Device functions tested
  • Device performance during testing
  • Standard’s allowances
  • Specification deviations
  • Labeling and evidence of compliance
  • Changes or modifications




  • In vitro companion diagnostic (IVD) device:  Provides information that is essential for the safe and effective use of a corresponding therapeutic product
  • General principles for codevelopment for contemporaneous marketing authorization for therapeutic product and corresponding IVD

Relevant Information:

  • Regulation: Risk Assessment, IDE Requirements, Submission
  • Prospective Codevelopment Planning: Analytical validation, intended uses, prototypes, prescreening
  • Therapeutic Product Clinical Trial Design: Early/Late, prognostic and predictive markers, prospective-retrospective approaches, identifying intended populations
  • Late Therapeutic Product Development: Training samples vs. validation samples,  effect of changes, bridging studies,  SPA,
  • Planning for Contemporaneous Marketing Authorizations : Coordinating review timelines, shipment, verification
  • Labeling






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