Viky Gilles Daniel Verna
Co-Founder and VP at confinis Corp (US) - Senior Consultant at confinis ag and med-HF (Switzerland)
< 1 min reading time
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. Inputs/comments would be greatly appreciated.
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Rob Packard Great question! The FDA also does a similar pre-clearance inspection for novel sterilization processes. Typically if you expect this type of activity, you should request a pre-sub meeting. The FDA will then be able to confirm if a pre-clearance is inspection applies to your device submission or not and answer the other parts of your question. It depends upon resources as well. I don't believe that the FDA will perform this type of inspection until after your submission has been accepted and you are in the substantive review phase. It is likely to delay the process of a normal 510(k). The inspection depends upon the reason. Some inspections focus on production and process controls, some on design and some on clinical studies. Pre-clearance inspections are generally not full QSIT. You can also email the person that is responsible for that specific guidance. They are usually a little more helpful than most when your question is specific to the guidance they are responsible for.
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Rick Rutherford I have performed many of the pre- and post-510(k) and PMA inspections. Typically, the reviewer will send to the FDA Investigator a list of items/questions that should be covered during the inspection. The Investigator will look at these issues and provide in the Establishment Inspection Report (EIR) any observations that addresses the reviewer's list, along with any other observations which the investigator which would find in the course of the inspection. Per CPGM 83.001 a QSIT would not be performed. Depending on the significance and/or inadequate findings, an FDA 483 Inspectional Observation form would be issued at the end of the inspection.
I have seen several inspections where a FDA 483 was issued and the reviewer requested the firm to address one or more of the items on the FDA 483. Other inspections where no FDA 483 was issued, the reviewer and CDRH has requested a response based on their information which may not be available to the Investigator.
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