This query was posted to a LinkedIn Group, but I think this group is more likely to have an answer...
Has anyone experienced an FDA 510(k) pre-clearance inspection? If yes, how long after the 510(k) submission was the inspection performed? Is the firm domestic or foreign? Did they review the DHF of the product under 510(k) review to ensure compliance with design controls? Or, did they perform a general QSIT level II inspection?
I am asking because the Infusion Pumps Total Product Life Cycle Guidance for Industry and FDA Staff (Draft) Document issued on December 2, 2014, states that 510(k) pre-clearance inspection could be considered.
------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------