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Posted On: 04/07/2024 10:38:11 PM
Post# of 86958
This is what I found
1. Listed or Registered: When no pre-market review is required (510-K exempted), however FDA still controls the label
2. Clearance: When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance.
3. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process. Following a successful submission of a premarket approval (PMA) or a Humanitarian Device Exemption (HDE), the device is given Approval by FDA.
4. Granted: Medical devices using the De Novo pathway must be Granted by FDA before they can be legally marketed in the United States. This is a relatively new term in the FDA lexicon.
Also this,
https://www.rimsys.io/blog/fda-listed-cleared...ed-granted
1. Listed or Registered: When no pre-market review is required (510-K exempted), however FDA still controls the label
2. Clearance: When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance.
3. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process. Following a successful submission of a premarket approval (PMA) or a Humanitarian Device Exemption (HDE), the device is given Approval by FDA.
4. Granted: Medical devices using the De Novo pathway must be Granted by FDA before they can be legally marketed in the United States. This is a relatively new term in the FDA lexicon.
Also this,
https://www.rimsys.io/blog/fda-listed-cleared...ed-granted
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