Do we need FDA Establishment Registration for Bone Screws?

R

RLDEARMOND

#1
I work for a small component Medical Device manufacturer. At a recent conference our CEO was told by a consultent that because we machine bone screws that we have to have an FDA a facility license as bone screws are finished devices.

I diagree as we do not sterilize, package, label or market the screws. We only machine the screws and return them to the comapny that markets them.

I believe the consultant is just trying to get his foot in our door ($$$) but I would like a second opinion.
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: Component Manufacturer

I work for a small component Medical Device manufacturer. At a recent conference our CEO was told by a consultent that because we machine bone screws that we have to have an FDA a facility license as bone screws are finished devices.

I diagree as we do not sterilize, package, label or market the screws. We only machine the screws and return them to the comapny that markets them.

I believe the consultant is just trying to get his foot in our door ($$$) but I would like a second opinion.
Without knowing the entire situation, I tend to agree with you about the consultant. I am not a FDA expert, but there are some people here in the Cove that are.
 

Ajit Basrur

Staff member
Admin
#3
Re: Do we need to go in for FDA Establishment Registration ?

I work for a small component Medical Device manufacturer. At a recent conference our CEO was told by a consultent that because we machine bone screws that we have to have an FDA a facility license as bone screws are finished devices.

I diagree as we do not sterilize, package, label or market the screws. We only machine the screws and return them to the comapny that markets them.

I believe the consultant is just trying to get his foot in our door ($$$) but I would like a second opinion.
Welcome to the Cove :bigwave:

There is an entire section on Orthopedic Devices under 21 CFR Part 888 that you can refer - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=888

Specifically, there is one medical device (Class II) under "metallic bone fixation fastener" -but not sure what your device is ?

Sec. 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

(b)Classification. Class II.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Do we need to go in for FDA Establishment Registration ?

I work for a small component Medical Device manufacturer. At a recent conference our CEO was told by a consultent that because we machine bone screws that we have to have an FDA a facility license as bone screws are finished devices.

I diagree as we do not sterilize, package, label or market the screws. We only machine the screws and return them to the comapny that markets them.

I believe the consultant is just trying to get his foot in our door ($$$) but I would like a second opinion.
From your description it sounds that you may be a contract manufacturer of medical devices. There are new registration requirements coming into effect October 1st, under which you may be required to register and list (as all contract manufacturers), see here:

http://elsmar.com/Forums/showthread.php?t=55942

Cheers,
Ronen (another "greedy" consultant ;)).

PS Please note that from your description one can't tell whether you are the legal manufacturer of those devices, because you didn't say whose name is on the label. Theoretically you could be placing finished medical devices on the market, with contractors doing the packaging, labeling, sterilization and distribution for you. I'm not saying that this is your situation, nor that it's common or even likely, just pointing out that your description leaves that possibility in place (I'm mentioning it for others that may read this at a later time).
 
Last edited:
R

RLDEARMOND

#5
Re: Do we need to go in for FDA Establishment Registration ?

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.
 

Ajit Basrur

Staff member
Admin
#6
Re: Do we need to go in for FDA Establishment Registration ?

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.
If you do not make a finished device, you are exempted from Establishment Registration but I will advise you to get in touch with your customer to understand the Product Code
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: Do we need to go in for FDA Establishment Registration ?

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.
If your products go into assemblies which eventually make up finished medical devices, along with other non-packaging components, or are further worked to make them into medical devices (e.g. coated - just making up an imaginary example), then you are not considered a contract manufacturer of finished medical devices and are therefore exempt. However, if all that separates your products from being "finished" is sterilization, packaging and labeling, then there might be some scenarios (depending, among other factors, on the specific products you make) where your products could be considered "finished" just as well, and thus you'd be subject to registration requirements. For example, many dental devices are sold non-sterile, for consequent sterilization by the user prior to first use; and could also be sold (exact same device) single packed and already sterilized. I know that this is not exactly your situation, but I'm trying to make a generalized point. For an answer specific to your case one must have access to the details. You could also direct an explicit question to the FDA and get an authoritative interpretation of the regs.

Good luck,
Ronen.
 
M

MIREGMGR

#8
No clarification of the 2013-rules boundary between a non-distributing contract manufacturer and a 21CFR 807.65(a) component maker has been provided yet.

As Ronen E notes, FDA has never made it fully clear whether a device that is "finished" but not yet ready for marketing because it hasn't been packaged, labeled and sterilized is a "finished device" or not. I hope that'll be sorted out as part of the 2013-rules transition.

Also note that under the different rules that the IRS is gradually rolling out for the 2.3% Medical Device Tax, you probably will be the manufacturer of record for the products you make as an FDA contract manufacturer or component maker, even though they are not yet packaged, labeled and sterilized, you do not distribute them and you are not FDA-responsible for them, unless the company for which you do the fabrication has a relevant patent on the mechanical or manufacturing aspects of their design. In that singular case, the company for which you do the work would be the manufacturer.
 
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