Frequently Asked Questions
Do I have to implement a quality system for a Class I device?
It depends on the requirements of the FDA classification regulation/product code.
Is ISO 13485 sufficient?
The FDA does not recognize ISO 13485 as being in compliance with FDA QSR (21 CFR part 820). Furthermore, ISO 13485 certifications are not equivalent to FDA QSR compliance.
The FDA does not have a time table on when you will be inspected. They can inspect you at any time with little notice. If you manufacture higher risk devices, you are more likely to be inspected.
What happens if I get inspected and it does not go well?
If you get inspected by the FDA, and they find many deficiencies with your quality system, they may issue a Form 483 Notice of Inspectional Observations. You will have a specific period of time to address the problems noted by the inspector.