FDA released draft guidance on Premarket Notification (510(k)) Submissions for Bone Anchors, with recommendations for information and testing that should be included in premarket submissions for devices used in the appendicular skeleton for attachment of soft tissue to bone.
This guidance is a reissuance of the Guidance Document for Testing Bone Anchor Devices from 1996, with updated content.
This draft guidance is not final nor presently in effect. To submit feedback for consideration prior to final guidance, FDA seeks electronic or written comments by March 6, 2017.
FDA released draft guidance on Premarket Notification (510(k)) Submissions for Bone Anchors, with recommendations for information and testing that should be included in premarket submissions for devices used in the appendicular skeleton for attachment of soft tissue to bone.
This guidance is a reissuance of the Guidance Document for Testing...
FDA released draft guidance on Premarket Notification (510(k)) Submissions for Bone Anchors, with recommendations for information and testing that should be included in premarket submissions for devices used in the appendicular skeleton for attachment of soft tissue to bone.
This guidance is a reissuance of the Guidance Document for Testing Bone Anchor Devices from 1996, with updated content.
This draft guidance is not final nor presently in effect. To submit feedback for consideration prior to final guidance, FDA seeks electronic or written comments by March 6, 2017.
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