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In the regulations for when it is acceptable to use a Third-party 510(k) reviewer, it says
The FDA must accredit persons to conduct initial 510(k) reviews no later than one year after enactment. Accredited persons may not review:
- Class III devices;
- Class II devices that are permanent implants or life sustaining or life supporting; or
- Class II devices which require clinical data, except the number in this group must not be more than 6 percent of total submissions (as defined by statute).
My question is about the third bullet - how do you know if your device *requires* clinical data. Are the conditions that describe this stated in a guidance or similar document?
thanks in advance!
The FDA must accredit persons to conduct initial 510(k) reviews no later than one year after enactment. Accredited persons may not review:
- Class III devices;
- Class II devices that are permanent implants or life sustaining or life supporting; or
- Class II devices which require clinical data, except the number in this group must not be more than 6 percent of total submissions (as defined by statute).
My question is about the third bullet - how do you know if your device *requires* clinical data. Are the conditions that describe this stated in a guidance or similar document?
thanks in advance!