The US FDA does not have formal "priority levels" for medical device registration in the same way it does for drug approvals, but it does provide mechanisms for expedited review of certain devices. These mechanisms are designed to speed up the approval process for devices that meet certain criteria. The following are key priority designations for medical device registration:

1. Standard Review:

   • This is the typical review process for most devices. The FDA evaluates the device submission based on the standard review timelines and requirements, which vary by device classification (510(k) or PMA). Class I devices usually undergo a less extensive review, while Class II and Class III devices require more scrutiny.

2. Expedited Review:

   • The FDA may offer expedited review for devices that address unmet medical needs or are intended to treat serious conditions. Expedited review can apply to both 510(k) and PMA submissions.

3. Breakthrough Device Designation:

   • The FDA offers this designation for devices that provide more effective treatment or diagnosis for serious or life-threatening conditions, where no other alternative treatments exist or the new device offers a significant advantage. This designation allows manufacturers to work closely with the FDA to speed up the review process and may include additional regulatory flexibility.

4. Priority Review:

   • Priority review is given to devices that offer significant improvements in the safety or effectiveness of treatment for serious conditions. Devices that qualify for this review are typically fast-tracked through the approval process, especially if they address critical healthcare needs.

5. De Novo Classification:

   • This pathway is for devices that are novel and do not have an existing predicate. It is often used for devices that are Class I or II but require more regulatory oversight. The De Novo process can provide a faster pathway to market for innovative devices that pose low to moderate risk.

6. Accelerated Approval (for certain PMA devices):

   • While not a common designation for medical devices, the FDA has some mechanisms under the PMA process that allow for faster approval, particularly for devices that show promise in treating serious or life-threatening conditions. This can include the use of surrogate endpoints or real-world evidence to support approval.

7. Humanitarian Device Exemption (HDE):

   • For devices intended to treat rare conditions affecting fewer than 8,000 patients in the U.S., the FDA offers a Humanitarian Device Exemption. This allows for approval with less clinical evidence but still requires demonstrating that the device has a reasonable assurance of safety and effectiveness.

These priority pathways help streamline the review process for devices that meet specific criteria, such as addressing unmet medical needs or offering significant benefits over existing treatments.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn