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?
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?
