Common Questions
Do I have to implement a quality management system for a Class I device?
It depends on the requirements of the FDA classification regulation/product code assigned to the device.
Is ISO 13485 sufficient?
No. The FDA does not recognize ISO 13485 as being in compliance with FDA QSR (21 CFR part 820). Furthermore, ISO 13485 certification is not equivalent to FDA QSR compliance.
Manufacturers of Class II and III medical devices are to be inspected by the FDA every two years. The FDA can inspect you at any time with little notice. The FDA prioritizes inspections by risk with greater priority given to higher risk devices and situations. If you manufacture devices that are implantable, life supporting or life sustaining, you are more likely to be inspected.
What happens if I get inspected and it does not go well?
If the FDA inspects you, and they find deficiencies with your quality management system, they may issue a Form 483 Notice of Inspectional Observations. You will have a specific period of time to address the issues noted by the FDA Investigator.