Frequently Asked Questions

Approved, Granted or Cleared – which term for what pathway?

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Compliance & Regulatory: MedTech

Unless a medical device is 510(k) exempt, all medical devices must be cleared or approved by the FDA before they can be legally marketed.

  • Granted medical devices: This is a relatively new term in the FDA lexicon. Medical devices using the De Novo pathway must be Granted by FDA before they can be legally marketed in the US.
  • Cleared medical devices: These medical devices are the ones that the FDA has determined to be substantially equivalent to similar legally marketed device. A manufacturer conducts a process called “Premarket Notification” or follows the 510(k) process to receive clearance from FDA.