510(k) Submissions Workshop – Fall 2018

On October 16, 2018, Danielle Humphrey led an Advanced Medical Technology Association (AdvaMed) workshop titled "510(k) Post-Clearance Process."

Topics of discussion:

  • Device modifications/design changes - quality system requirements (QSR) compliance
  • Deciding when to submit a new 510(k) for a device modification
  • Obtaining information about another company's devices
  • Total Product Life Cycle considerations
  • Promotional practices
  • Post-clearance exercise

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