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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,
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,