FDA Revises Guidance on 510(k)s for Atherectomy Devices
The FDA clarified what information devicemakers should include in their 510(k) premarket submissions for peripheral vascular atherectomy devices in a new final guidance.
Source: The GMP Letter
The FDA clarified what information devicemakers should include in their 510(k) premarket submissions for peripheral vascular atherectomy devices in a new final guidance.
Source: The GMP Letter