Do we need FDA Establishment Registration for Bone Screws?

[ystark]

I contacted the FDA directly and their response was that as long as we do not package, label or sterilize the device then we are exempt from registration.

Thanks to all those who gave their input.

I have the exact problem that you had . We are a machine shop that supplies medical implants and instruments to our customer's specifications. We do not label, package or sterilize our products. Yet our customer insists that, under the FDA definition, our products are considered "finished devices" - and therefore we are considered a "contract manufacturer" and are demanding we register and list with the FDA. Who did you contact at the FDA? Or where can I find the type of exemption you describe clearly stated in the FDA regulation.

 

[MIREGMGR]

I have the exact problem that you had . We are a machine shop that supplies medical implants and instruments to our customer's specifications. We do not label, package or sterilize sterilize our products. Yet our customer insists that, under the FDA definition, our products are considered "finished devices" - and therefore we are considered a "contract supplier" and are demandeing we register and list with the FDA. Who did you contact at the FDA? Or where can I find the type of exemption you describe clearly stated in the FDA regulation.

The distinction between Contract Manufacturing and "component making" is defined at 21CFR 807.65.

Your customer of course can demand anything they want, and you can agree to meet their demands or not. If you choose not to meet their demands, they can take their business elsewhere. Or, you can decide that their demands are unreasonable and tell them to go elsewhere. That's the nature of business relationships. As long as you do not distribute to end users, there is no FDA requirement that determines whether your status is Contract Manufacturer or Component Maker.

The core reason why your customer might want to be Registered and to List as a Contract Manufacturer is that they are Registered and List as a Specification Provider. They however can change their Listings to Manufacturer status, in which case it's perfectly fine for them to buy from a component maker.

Some companies and consultants apparently think that a Manufacturer must perform physical manufacturing in order to be have that status. My understanding is that that belief is incorrect. The process of turning a non-medical-device object, such as the product of a component maker, into a medical device is a legal event. Who does what aspects of the physical processing--the Manufacturer, a contract manufacturer and/or a component maker--is a secondary consideration.

Who did you contact at the FDA?

FDA DSMICA. 800-638-2041.

 

[MIREGMGR]

I contacted the FDA directly and their response was that as long as we do not package, label or sterilize the device then we are exempt from registration.

I don't know the precise question that you put to DSMICA to which they responded, but per my understanding the key consideration is that a component maker must not either distribute to end users themselves, or provide their products to a Distributor, Reseller, Repackager or (in most cases) Kit Packer. They must provide their output only to a Manufacturer, or to a Contract Manufacturer on a Specification Developer's behalf.

The Manufacturer or Contract Manufacturer doesn't have to further physically process those objects, but the Manufacturer, Specification Provider or Contract Manufacturer does have to have legal possession of them. It is during this legal possession that the components legally become medical devices.

I'd think the most likely reason why a customer might insist that a supplier have a regulatorily responsible FDA status is that they (the customer) want to be a Distributor, and not be regulatorily responsible for the medical device products.

Someone must be regulatorily responsible for every medical device. If the maker of a product disclaims responsibility for it, but their customer is a distributor, my understanding of precedent is that FDA eventually will come after the product maker...not the distributor...even if the product maker claims that they're exempt under 21CFR 807.65(a).

 

[treesei]

I want to make it clear that we are a machine shop that produces many components of medical devices but we do not sterilze, package or market those components. We are just a machine shop. The customer does all the marketing, sterilization, packaging and shipping of the finished product.
If I interpret the regulation properly I don't believe the new (October 1st) regulations apply to us for facility registration.
I'm just trying to get some clarification as the regulation is vague as to who must list and register.

Below is from FDA's website:

"A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized."

http://www.fda.gov/MedicalDevices/D...rements/QualitySystemsRegulations/default.htm

Also from FDA website (updated 10/11/2012):

"Contract Manufacturer - Manufactures a finished device to another establishment's specifications."

http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm

The same website also describes who must register and list.

 

[ystark]

The short definition of "finished device" (and notice that it doesn't contain the word "medical") is trying to encompass thousands of devices produced throughout the world. Everything from surgical instruments, to implants or wheelchairs and crutches. Many of these must be sterilized to be "suitable for use". Some do not require sterilization at all. Is a surgical instrument or implant that is not sterilzed, yet "capable of functioning" to be considered a "finished device"?

 

[MIREGMGR]

Below is from FDA's website:

"A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized."

http://www.fda.gov/MedicalDevices/D...rements/QualitySystemsRegulations/default.htm

It must be noted, though, that notwithstanding the above definition in the law, FDA's working definition normally takes into account the intent of the maker and who they sell to.

For instance, a wood products company that bulk-fabricates flat, rounded-end wooden sticks in various sizes is not considered a medical device maker just because some sizes of those sticks are capable of being used as tongue depressors. Instead, that bulk wood products company is treated as a component maker, and their product...sold to a medical device company that does little more to the product than re-package and label it...legally becomes a medical device while in possession of that medical device company.

This would be true, in my understanding, even if the wood products company specialized in fabricating sticks that are within the size and shape ranges for tongue depressors...as long as their focus is on making wood products, and their sales of wood products that will end up as tongue depressors are to Manufacturers, Specification Providers and/or Contract Manufacturers, and not anyone else.

My view is that the OP's metal fabricator is an analogous example.

 

[MIREGMGR]

Is a surgical instrument or implant that is not sterilzed, yet "capable of functioning" to be considered a "finished device"?

The purpose of the FD&C Act definition is to provide a basis for the FDA to hold that someone in the realization chain for every medical device, prior to that medical device reaching an end user, is responsible for that device.

So, if you fabricate a surgical instrument and sell it in bulk to me, and I sell it to end users, either you or I is regulatorily responsible for that device. We can negotiate or fight about which of us it should be if we want, but most assuredly it will be one of the two of us. If I want to be regarded as a non-regulatorily-responsible Distributor, then you must be the Manufacturer. If you want to be regarded as a non-regulatorily-responsible component maker, then I must be the Manufacturer.

 

[treesei]

Is a surgical instrument or implant that is not sterilzed, yet "capable of functioning" to be considered a "finished device"?

By definition, yes.

I used to work for a company which has a facility whose products are 90% non-medical electronics (ISO 9001 QMS) and 10% medical devices (ISO 13485 QMS). It is registered and finished devices (all sold to OEM's) listed.

My take: If a machine shop makes a lot of products some of which happen to fall into the fit, form, and function of certain finished devices, as long as the products are not intended by the shop to be medical devices, the shop should not be considered a device manufacturer even company A may buy such "off-shelf" products, turn them into a device by packing, labeling (intended use comes into play here), sterilization, and assume full responsibilities. However, if the shop makes such products per company A's specifications or exclusively for company A, the shop becomes a contract manufacturer and the products become finished devices even they are only a small part in the product portfolio.

This will be an interesting situation. On one side, company A wants to mitigate risks and put some responsibility to the machine shop. On the other side, the shop wants to avoid such responsibility as much as possible.

 

[ystark]

I just spoke with the FDA and was given a different interpretation. These devices ARE considered finished devices and our company therefore is considered a "contract manufacturer". This means we must register and list our devices with the FDA and pay their annual fees.

 

[Ajit Basrur]

Thanks for sharing this info.