FDA Inspections - Questions from a Device Manufacturer Submitting 510k

R

regmeddevices

#1
We are submitting 510k. I'm a bit confused about FDA inspection. Experts please help.

1. Can FDA conduct an inspection while they are reviewing our 510k application?
2. Do we need to put some plan in place to handle the inspection?
3. What would they typically look for in an inspection? According to my understanding they will look for compliance with FDA regulations applicable to our device. Is that correct?

Best,
 
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MIREGMGR

#2
Re: FDA inspections

We are submitting 510k. I'm a bit confused about FDA inspection. Experts please help.

1. Can FDA conduct an inspection while they are reviewing our 510k application?
Yes if something about the 510(k) process triggers a heightened concern, or there is sufficient risk-novelty associated with the design or manufacturing process that it's decided an inspection is needed, or your firm already has an inspection-priority score that's relatively high within your region and a decision is made that the 510(k) process tips it over the edge.

In general, though, my understanding is that the inspection schedule is based on other factors than your 510(k) activity.

2. Do we need to put some plan in place to handle the inspection?
It's a good idea for every device establishment to have a plan in place for who does what when an inspector shows up. In theory, that eventually will happen at every establishment.

3. What would they typically look for in an inspection? According to my understanding they will look for compliance with FDA regulations applicable to our device. Is that correct?
If the inspection is 510(k) related, no doubt they'll want to review specific issues. If it's general, they'll follow the QSIT 1 process. For more information on exactly how it may proceed, go to the CDRH site and search on "QSIT 1" for relevant guidances and the inspection manual.
 
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