Who is the Specification Developer in this case?

[Mikeee]

I have a somewhat tricky situation. My company company connects OEM's with (mostly) German manufacturers and also performs QC in between. We have a customer that supplies prints for a particular class 2 device (no 510k). The manufacturer has a 510k for a very similar part. When exporting to us, the manufacturer wants to use their FDA listing information since they have a 510k and are worried that if they use the listing information from our customer, they might have regulatory problems. However, the customer is supplying prints that the parts are to conform to and so is the "Specification Developer", and so I think that the customer's listing information should be used. I'm guessing the problem is that there may be some design overlap so that even when making the parts to the customer's prints, the parts also fall under the manufacturer's 510k (I'm speculating here).

So who's listing information should the manufacturer use when exporting?

Thanks!

 

[Ronen E]

Are you saying that this medical device falls in two separate ProCodes, one requiring a 510k and the other not?

 

[Mikeee]

Yes, that seems to be the case. I've noticed that for many parts we see, mostly class 1 devices, the OEM's and manufacturers use different Product Codes. Now with the new regs for FY2013 I've been requesting the manufacturers to use the customer-supplied Product Codes when the customer supplies prints.

For this case, yes, the customer uses the catch all Product Code LXH (Orthopedic Manual Surgical Instrument) and the manufacturer uses a more specific Product code that falls under a 510k.

It seems to me that the customer should have a 510k, but they don't, and my company doesn't really have a say in the matter. The customer is a major OEM so I'm fairly sure they have their reasons.

 

[MIREGMGR]

It's poor regulatory practice for your customer and a second party to create an agreement for fabrication of a medical device without including in that agreement all of the relevant aspects of regulatory responsibility.

I don't think we can fully answer your question without knowing more specific information about the product and the respective regulatory situations.

I'm curious as to what kind of regulatory trouble the fabricator could have if they were documented to be a Contract Manufacturer and performed consistent with that status...assuming of course that your customer, the other party, is conforming to their own regulatory obligations.

This should have been sorted out up front.

 

[Mikeee]

Our customers enter into a contract with us, as do the manufacturer, so there is no communication directly between the two - only through us. I agree this should be handled up front and that is why I am here posing the question before a contract is made. There is no contract at this point.

I found out that the customer does not have a 510k because the intended use does not require it since the device in question will be removed before the end of surgery. The same instrument could, in general, be used as an implant and so in that case in would need a 510k. I would guess then that there should be no problem for the manufacturer to make the product under a listing other than their 510k, even if the product is identical to that which is described in their 510k, as long as the contract follows the specification of the OEM and their intended use. Correct? Did I make any sense?

 

[MIREGMGR]

Our customers enter into a contract with us, as do the manufacturer, so there is no communication directly between the two - only through us.

Regulatorily, that's a complicated business model.

If I was either of the parties other than your company, I'd refuse to do business on such a basis without knowing who the third party was. As revealed by Warning Letter actions, FDA expects that both responsible Manufacturers (including Specification Developers) and registered-Establishment Contract Manufacturers will verify that their counter-party has a proper regulatory stance.

I don't see how that expectation can be met if there's a masking company in the middle...unless the responsible Manufacturer reports your company as the Contract Manufacturer, and the fabricating company regards your company as the responsible Manufacturer. I gather from your information here that you aren't set up for that latter scenario.

I would guess then that there should be no problem for the manufacturer to make the product under a listing other than their 510k, even if the product is identical to that which is described in their 510k, as long as the contract follows the specification of the OEM and their intended use. Correct?

I don't think so. The fabricator, if they are a registered Establishment, is expected by FDA (as indicated by past-several-years Warning Letters) to verify for the apparent-medical-device product they fabricate that their customer appears to be regulatorily compliant. If the product may be of a type that needs a 510(k), and the fabricator doesn't know who the third company is...how do they do that?

If the product went to someone that didn't get a 510(k) and wasn't registered, my expectation based on past FDA actions would be that the fabricator would be held co-responsible.

 

[Mikeee]

99% of our business is class 1 devices, so we rarely deal with 510k's, so that keeps the pressure off to some extent as there's less regulatory controls needed. We are listed as a contract manufacturer and we verify the regulatory stance of our suppliers, and our customers do the same to us, so (I think) it all works out. We have yet to be audited by the FDA so hopefully it's set up correctly. To the best of my knowledge it is, but I admit I'm no regulatory guru.

In this case the 510k does not apply since the customer does not need or have one, and the fabricator is manufacturing to the customer's specs. It just so happens that the fabricator has their own 510k for a nearly identical product that could be implanted. We don't ever sell class 2 medical devices of the fabricator's design. The specs all come from the customer side.

I appreciate your input!

 

[Ronen E]

Who is labeling the device? What is the intended use indicated in the IFU? The device's classification (and resulting need or lack thereof for a 510k) are derived from the intended use, as you've explained so well in this case. If the labeling says it's implantable, this is how it would be classified, no matter what the contract or other documents say. If it's labeled to the customer's spec as transient then this is what it is and it matters not that another config has a higher class and a 510k.

Two devices could be physically identical but regulatory different if they have different intended uses. Labeling and verbal etc. conduct are paramount in that regard.

 

[Mikeee]

In terms of labeling, there is no lasermarking on the device at all, but perhaps they are distributed by the customer in a labeled bag - I don't know. We supply only the device in bulk. Also, I haven't seen the actual IFU. I only have in writing from the customer that the intended use is transient and thus no 510k is needed, and that they list the device under product code LXH. I hope that's good enough for the FDA!

 

[Ronen E]

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/ :

The Federal Food, Drug and Cosmetic Act (FFDCA) is the law under which the FDA takes action against regulated products. Specifically:

Section 201(k) defines 'label' as a:

'display of written, printed, or graphic matter upon the immediate container of any article...'

The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper, if any there be, of the retain package of such article, or is easily legible through the outside container of wrapper.'

Section 201(m) defines 'labeling' as:

'all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or

(2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.

So, labeling is not limited to the device label itself (or laser markings).

From your description above I gather that your customer in this case is the device labeler (including assignment of intended use) and therefore is a legel / regulatory responsible medical device Manufacturer. Whoever supplies them the device in bulk is merely a component supplier - IMO not a Contract Manufacturer - because they don't make a finished medical device; unless the devices are supplied in a way that they could as well be distributed as finished devices with no further processing (such further processing can include packaging and/or labeling).