510(k) Submissions: 21 Elements You Need to Know

  • By: Staff Editor
  • Date: March 15, 2016
  • Source: ComplianceOnline

Does your medical device require a 510(k) application? The process of submitting a 510(k) application can pose many challenges for device manufacturers as each 510(k) submission is dynamic depending on the type of device, the risk level, its history, etc. A final 510(k) submission should be a completed comprehensive document including all 21 sections and other information needed for approval by the FDA. Therefore, it is vital to have a strong understanding of the latest 510(k) submission requirements and how they relate to your device.

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