Challenging the regulations (By QRM)

Dear All,

In view of the regulations (a particular requirement) can we do any risk management studies to justify the requirement and get it approved by regulatory before its implementation.

Do any guideline or regulations support it or it is mandate to follow the regulations inpractice eventhough you can prove or justify the requirement.



I’m not sure I understand your question.

A regulation is a law so, yes, you have to follow it. Without further information, I see 2 angles to your question. Note that my experience with regulations is US FDA so my thoughts are biased in that direction.

  1. Quality Systems Regulation (12 CFR 820). The FDA will not “approve” your compliance to a particular regulation. They will assess your compliance to the regulation (as defined by your procedures) and determine if you’re compliant. If not, they write a 483. There may be times in an assessment where you can’t show specific evidence of compliance but that does not relieve you of having the controls (SOPs) in place. For example, if you are assessed early on in a product’s life, you may not have any Customer Complaint data. However, you will still be expected to have the procedures in place to meet the regulation. So if you’re asking if the FDA will give you a 483 if you don’t have specific evidence showing compliance to a regulation, the answer is maybe. If you can show the controls are in place and meet the regulation, then probably not.

  2. Product approval is a separate issue but again, they will not “approve” a requirement related to the product - only approve the product as an entity (product, labeling, etc.) based on your evidence of safety and efficacy and/or comparison to a predicate. So if you’re asking if FDA would approve a product based on requirements only, the answer is no: you must demonstrate safety and efficacy. Part of that evidence might be a risk analysis with mitigations to better ensure safety. If that’s the case, you would need to show objective evidence that the control is implemented and is effective.

I don’t know if any of that answers your question. If not, can you be more specific about what you’re considering?