Required to Register with FDA?

Quality_Goblin

Involved In Discussions
We are ISO 13485 certified and have never had any customer concerns regarding our processes. However, we have just acquired a new customer who is wondering why we are not FDA registered. Is this really an issue? We are compliant to 21-CFR-820 and that is mentioned in our Quality Manual. How would you handle this customer concern?
 

GStough

Leader
Super Moderator
We are ISO 13485 certified and have never had any customer concerns regarding our processes. However, we have just acquired a new customer who is wondering why we are not FDA registered. Is this really an issue? We are compliant to 21-CFR-820 and that is mentioned in our Quality Manual. How would you handle this customer concern?
A couple of questions: 1) Do you (your company) manufacture finished medical devices under your company's name? 2) Do you manufacture finished medical devices as a contract manufacturer? There are several ways a company can be registered with the FDA and these are just two of them to consider. We have suppliers who are not registered with the FDA but are compliant to 21 CFR 820 because they have customers who are registered with the FDA and like to know that their suppliers are at least compliant. Our suppliers who are not registered with the FDA have a wide customer base that includes several industries, so it may not be necessary for them to register with the FDA when most of their customers are in other industries.

I hope this helps. :)
 

Quality_Goblin

Involved In Discussions
A couple of questions: 1) Do you (your company) manufacture finished medical devices under your company's name? 2) Do you manufacture finished medical devices as a contract manufacturer? There are several ways a company can be registered with the FDA and these are just two of them to consider. We have suppliers who are not registered with the FDA but are compliant to 21 CFR 820 because they have customers who are registered with the FDA and like to know that their suppliers are at least compliant. Our suppliers who are not registered with the FDA have a wide customer base that includes several industries, so it may not be necessary for them to register with the FDA when most of their customers are in other industries.

I hope this helps. :)
1) No we do not manufacture our own company name
2) No we do not manufacture finished parts. Only components.
 
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