J
JasonDanner13
I wasn't sure how to make another thread so I added it in here. I am part of a startup company who got a 510K as a contract manufacturer. We sent a design to our predecessor company, they built the medical device, and sent it back to us for packaging and sterilization.
Now, we have deemed our manufacturing process superior to our predecessor and want to manufacture the piece ourselves. The process changes we instituted do not change the product in terms of looks or function. It may make the device safer in a worst case scenario, but I wouldn't say our device is superior in safety either. Rather, we just optimized the process to create better flow, shorten the manufacturing process, and minimize the amount of raw materials we use in the process.
We do have information that could support our product being safer than the predecessor, but not significantly safer.
My question is: Do we need to get another 510K since we did alter the manufacturing process? I've read some of the FDA's wording on this and they tend to use the adjective "significant" changes to the manufacturing process. But, I don't know how to categorize what is significant and what is not. And because of this confusion, I am not sure if we need to apply for another 510K or not.
If anyone could help I'd appreciate the input!
Now, we have deemed our manufacturing process superior to our predecessor and want to manufacture the piece ourselves. The process changes we instituted do not change the product in terms of looks or function. It may make the device safer in a worst case scenario, but I wouldn't say our device is superior in safety either. Rather, we just optimized the process to create better flow, shorten the manufacturing process, and minimize the amount of raw materials we use in the process.
We do have information that could support our product being safer than the predecessor, but not significantly safer.
My question is: Do we need to get another 510K since we did alter the manufacturing process? I've read some of the FDA's wording on this and they tend to use the adjective "significant" changes to the manufacturing process. But, I don't know how to categorize what is significant and what is not. And because of this confusion, I am not sure if we need to apply for another 510K or not.
If anyone could help I'd appreciate the input!