FDA 510(K) submission question

srinu

Starting to get Involved
#1
Dear All,
I would like to know the guidance from our group regarding 510(K) submission.
Our Company X buy the DHF and complete test reports from company Y and company Y has 510(K) approval so now our company would like to apply for 510(K) on our name.
Our plane is like
1.Our predicate device is company Y 510(K)
2.Design,materials,manufacturing,sterilization and packing all are identical and same manufacturing facility as company y
3.Only use our specifications like part numbers ,labelling..etc.

My question is
1.Do we need to perform any performance tests? or the data which we got from company Y is enough to submit for 510(K) application (All are identical and the same manufacturing facility)?

Please give me your valuable answers.

Thanks in advance.
 
Elsmar Forum Sponsor

Watchcat

Trusted Information Resource
#2
To be clear, your predicate is not the other company's 510(k), it is the other company's device.

It sounds like you just want to be able to sell their device as your own, without making any changes to the physical device or to its intended use?

The same manufacturing facility is good, but I think a key question is whether your device is also going to be manufactured in that facility with the same validated manufacturing process. As a regulated product, a medical device is ultimately defined by its specifications and a manufacturing process that has been validated to show that it will reliably produce devices that meet those specifications.

If the tests were done on devices that were manufactured by the same validated process that will be used to manufacture your device, then those tests are equally applicable to your device, so I wouldn't think repeating them would serve any purpose.

"Specifications" is tricky. People toss this term around like a rubber ball. Changing part numbers will not "raise any new questions of safety and effectiveness." Labelling might, depending on what you are changing on the labelling. What impact "etc" might have, I can't say.

This is definitely not my strong suit, but I think I'm pretty much on point with what I have said so far. Maybe someone else can pick it up from here and add some clarifications.
 

srinu

Starting to get Involved
#3
To be clear, your predicate is not the other company's 510(k), it is the other company's device.

It sounds like you just want to be able to sell their device as your own, without making any changes to the physical device or to its intended use?

The same manufacturing facility is good, but I think a key question is whether your device is also going to be manufactured in that facility with the same validated manufacturing process. As a regulated product, a medical device is ultimately defined by its specifications and a manufacturing process that has been validated to show that it will reliably produce devices that meet those specifications.

If the tests were done on devices that were manufactured by the same validated process that will be used to manufacture your device, then those tests are equally applicable to your device, so I wouldn't think repeating them would serve any purpose.

"Specifications" is tricky. People toss this term around like a rubber ball. Changing part numbers will not "raise any new questions of safety and effectiveness." Labelling might, depending on what you are changing on the labelling. What impact "etc" might have, I can't say.

This is definitely not my strong suit, but I think I'm pretty much on point with what I have said so far. Maybe someone else can pick it up from here and add some clarifications.
Dear Watchcat,
Thanks for your answer.
Yes, our predicate is other company product
Yes our device is also going to be manufactured in the same validated process...
Labelling only we will change company name and address..etc i think it will not effect any safety of the device.

Any comments are welcome. Please look on this ...
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#4
This is a pretty unique situation. [email protected] might be better suited to the specifics as this is something few people have dealt with.

I think you need to have the same equipment and details the original company had or how could you test device changes or complaints?
 

Watchcat

Trusted Information Resource
#5
This is a pretty unique situation.
Actually, I don't think it is all that unique, just not "innovative" so very low profile.

In old industry, companies that sold medical devices often wanted to fill gaps in the product offerings. (Think "one-stop shopping" and "frequently bought together.") They didn't want to develop new devices; they wanted to sell existing devices. They didn't especially want to manufacture these devices, either. So they worked out an arrangement with a company that already manufactured the device they wanted. They would be able to brand and sell it as their own; the other company would continue to manufacture the devices. (How long has it been since most companies actually manufactured all, or even most, of the products that they sell?) Win-win.

More recently, this has exploded with the advent of remote home patient monitoring. Now everybody and their brother wants to brand pulse oximeters, stethoscopes, etc, as their own, so they can sell a "home monitoring kit" (not necessarily a kit as FDA defines them) to go along with their software. Like cell service providers pushing phones so you will use their service. Just like the cell service providers, they don't want to develop or manufacture these devices, just sell them so people will use their service.

If the contractual arrangement is solid, the manufacturer will give them access to all the information they need for regulatory compliance. Regardless, the manufacturer may often handle device changes and even complaint, because it's really the manufacturer's device.

I think some or all of this may fall under "relabeling," but the regulatory burden is often too low to need any significant RA expertise, so I don't have much in the way of first-hand knowledge.
 
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