Design Control for Repackager-Relabeler

[Victoria7]

I am new to medical device and the company I work for doesn't have a Design Control Procedure. Everything I read says we need it. The CEO says we buy finished 510k's and put them in a convenience kit using the customer specs therefore we are not designing anything. The company has an ISO 9001:2008 certification with thier QSM saying they are exempt because of the reasons mentioned above.I found a LOT of info in FDA Guidance for Design Control, Medical Device QSM Compliance guide, 21CFR 820 and ISO 9001:2008. Looking for clarity.
Confused

 

[MIREGMGR]

Everything I read says we need it.

What have you been reading?

You buy devices, and sell kits. Are the devices you buy in bulk form, such that you are adding the primary packaging and the only label? Or are they individually packaged, and you leave that primary packaging intact and place the packaged product into your kit overpack, which then gets an overlabel describing the kit's contents?

In the former case, you're probably a repackager/relabeler. In the latter case, you're only a kit-packer.

In either case, I think it's unlikely that it could be concluded that you have design responsibility.

The only circumstance where that might apply is when a kit packer buys non-medical-device items from a general manufacturer, and--in the process of creating kits with them--re-purposes them for a clear medical device purpose. In that case, the kit packer is the most likely party to end up with medical device Manufacturer responsibility, and sometimes that can entail design responsibility so as to encompass the process by which a determination has been made that the product is suitable for the medical-device intended use.

 

[Victoria7]

We are a repackager/relabeler but we also sterilize the kits. In the past FDA has given them a 483 for not implementing Design Control while ISO has not??

 

[MIREGMGR]

We are a repackager/relabeler but we also sterilize the kits. In the past FDA has given them a 483 for not implementing Design Control while ISO has not??

Sterilization is a manufacturing activity. That's normal for kit packers. Manufacturing and design of course are separate.

It's always dangerous to reach conclusions from so little information, but it certainly would seem on the face of the situation as if perhaps the FDA inspector might have erred in that one regard.

It's really dysfunctional to add a design control process to a QMS when no design activity is undertaken. It's hard to write, hard to maintain and certainly hard to explain in subsequent audits and inspections.

If it hasn't been too long since the FDA's inspection in question, you might want to address all of the other issues that you think are needed, then request an explanation from the FDA of specifically what the inspector was reacting to, in making that citation.

 

[Victoria7]

Thanks miregmrg for your input. It gives me a lot to think about and share with the rest of the team. Your the best.

I have visited the forum several times scanning through different posting for information but this is the first time I have posted. I'm sure i'll be back.

 

[IAmLearning]

Let me re-ask this question this way:
If an FDA registered repackager/relabeler company buys products from an FDA registered manufacturer/sterilizer company, and the manufacturing company does all the repackaging/relabeling work , and simply ships the product to the repackager/relabeler location, then what Quality Control documentations/procedures does the repackager/relabeler needs to have onsite to ensure they are in compliance with FDA's Quality Control regulations?

Thanks

 

[MIREGMGR]

Repackaging and relabeling are usefully discussed at https://www.fda.gov/MedicalDevices/...dicalDeviceQualitySystemsManual/ucm122391.htm. You can review the discussion there to verify that your classification of your business is correct.

As stated at that location, a repackager / relabeler is a Manufacturer and as such, must have a full QSR-compliant quality system.

If a Manufacturer utilizes a third party to conduct some or all of their manufacturing operations, that third party is a supplier. The Manufacturer must have systems in place to adequately control their supplier(s) so that the Manufacturer can demonstrate that the Manufacturer's product(s) comply with applicable regulations, etc.

 

[CBAL08]

I have a problem. A company has a distributor in US and all products are 510K cleared. Would it be possible to change the distributor to Kit assemblers who in addition would also perform the Service and maintenance activities of the complaint goods that are in the US market? What would be the regulatory implications for this kind of facility? Do they have to follow the Full QSR and be audited by FDA inspectors? Please help.

 

[MIREGMGR]

A company has a distributor in US and all products are 510K cleared. Would it be possible to change the distributor to Kit assemblers who in addition would also perform the Service and maintenance activities of the complaint goods that are in the US market?

That's a business decision. The FDA's role doesn't include permission-giving for such changes to your business arrangements.

Of course, all of the participants in a medical device marketing channel must comply with the regulations that apply to their role.

What would be the regulatory implications for this kind of facility? Do they have to follow the Full QSR and be audited by FDA inspectors?

Per https://www.fda.gov/MedicalDevices/...urDevice/RegistrationandListing/ucm053165.htm, a kit packer must have a full quality system relative to their scope of activities, and is subject to FDA inspection.