Is a component of a pedical screw system considered a finished medical device?

apestate

Quite Involved in Discussions
#1
I realize this question has been addressed in a previous thread, but due to a mental block on my part...

For example, a 21CFR 888.3050 type medical device consists of screws, frames, hooks rods and various components.

The entire device went through a 510k premarket notification process and was deemed substantially equivalent to devices already legally marketed in the United States.

We want to work for the company that markets the system, and we want to supply them with the titanium screw component. Are our activities on the device regulated by the FDA?

Do we have to also file 510k premarket notification to produce this one component?

Or do we merely have to list our company with the FDA and then get it on with our customer?
 
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apestate

Quite Involved in Discussions
#2
I'm close to a determination here personally but I'm still stuck on this detail: (from the FDA device advice website)

Component Manufacturers

A "component" is defined by 21 CFR 820.3 (c) as "any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device." Component manufacturers are excluded from the QS regulation by 21 CFR 820.1 (a)(1). Current FDA policy is to rely upon the finished device manufacturer to assure that components are acceptable for use. Component manufacturers are not routinely scheduled for GMP inspections; however, FDA encourages them to use the QS regulation as guidance for their quality system.

Contract Manufacturers

A person(s) that manufactures a finished device under the terms of a contract with another manufacturer is a contract manufacturer. The agreement between the manufacturers should be documented in a written contract. Contract manufacturers of finished devices shall comply with applicable requirements of the quality system and shall register their establishment with FDA. Depending on the circumstances, both the contractor and manufacturer may be held jointly responsible by FDA for the activities performed.
Of course, the FDA defines medical devices as :
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory...
I'm not sure... are we component manufacturers or contract manufacturers, or will the customer determine which? What's the difference
 

Scott Catron

True Artisan
Super Moderator
#3
My understanding is that if you supply a component that is installed in a medical device before it is sold to a user, the component is not a medical device.

Contrast this with supplying consumables that are used in a medical device. The consumables are regulated as if they were a medical device.
 

Al Rosen

Staff member
Super Moderator
#4
Scott_Catron said:
My understanding is that if you supply a component that is installed in a medical device before it is sold to a user, the component is not a medical device.

Contrast this with supplying consumables that are used in a medical device. The consumables are regulated as if they were a medical device.
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Al Rosen

Staff member
Super Moderator
#5
atetsade said:
I'm not sure... are we component manufacturers or contract manufacturers, or will the customer determine which? What's the difference
You are not manufacturing the finished device, but supplying a component.
 
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