Help on Medical Device Manufacturing - New Medical Device Company

[DDsystems]

Hello,

I started a new medical device company and we are currently going through a 3rd party review for our 510(k). We are a Class II device that uses an iPhone as the main component and has a holder around it. We are also GMP exempt.

My main question is that this is our first time manufacturing a medical device and we are confused on what you can and cannot do. After research it looks like only we have to be registered since we are the final component manufacture. Does that mean we can insert a battery then package the device and we are good to go?

Also onto the manufacturing side, are we able to outsource all the components to whoever we would like and FDA does not care about that? Are we able to create any kind of mold or does it have to be specially made from an approved factory?

Thanks for the help in advance.

 

[Ronen E]

Hello,

I started a new medical device company and we are currently going through a 3rd party review for our 510(k). We are a Class II device that uses an iPhone as the main component and has a holder around it. We are also GMP exempt.

My main question is that this is our first time manufacturing a medical device and we are confused on what you can and cannot do. After research it looks like only we have to be registered since we are the final component manufacture. Does that mean we can insert a battery then package the device and we are good to go?

Also onto the manufacturing side, are we able to outsource all the components to whoever we would like and FDA does not care about that? Are we able to create any kind of mold or does it have to be specially made from an approved factory?

Thanks for the help in advance.

Hello and welcome to the Cove

If you have the whole device manufactured somewhere else and all you do is insert a battery and package then I'd tend to think that the facility supplying you with the device (minus battery) should be registered as well, as a contract manufacturer. That would normally require you to register as a specification developer, but since you also perform an assembly step and the packaging you might need to register as a manufacturer as well.

Whoever supplies the components/ingredients to the manufacturer who supplies you the finished device is exempt from registration on account of that activity (if that's what you meant by "outsource all the components to whoever we would like and FDA does not care about that").

Regarding moulding, there are likely to be no applicable specific requirements since (I assume) this is not an invasive device and there are no special cleanliness expectations. However, please note that biocompatibility requirements apply where there is contact between the moulded part(s) and the user.

I hope that helped you a bit, please feel very welcome to post more questions here. If you want to share confidential information and receive more definite answers please send me a private message.

Cheers,
Ronen.

 

[DDsystems]

Hi Ronen,

Thank you so much for helping clarify. I have a couple more questions if that is alright.

Anyways, my product is very basic it is a goggle system that holds an iPhone in front of the user's eye so that it can record eye movements. It consists of a frame which houses a little LED system that is powered by a battery. We are a class II device like I stated and we are submitting our 510(k) to a 3rd party.

My question is what is our next steps for production. It is very hard to figure out exactly what FDA is requiring in terms of component manufacturing. We are trying to save money since we are a start up so we don't want to manufacture all ourselves as that would be too expensive. We haven't had good luck with getting a medical device manufacture as they were also very expensive. We are trying to get a regular manufacture that isn't interested in getting registered. So where do we go with it?

Any suggestions would be much appreciated!
Thanks,
Alex Bock

 

[Ronen E]

Hi Ronen,

Thank you so much for helping clarify. I have a couple more questions if that is alright.

Anyways, my product is very basic it is a goggle system that holds an iPhone in front of the user's eye so that it can record eye movements. It consists of a frame which houses a little LED system that is powered by a battery. We are a class II device like I stated and we are submitting our 510(k) to a 3rd party.

My question is what is our next steps for production. It is very hard to figure out exactly what FDA is requiring in terms of component manufacturing. We are trying to save money since we are a start up so we don't want to manufacture all ourselves as that would be too expensive. We haven't had good luck with getting a medical device manufacture as they were also very expensive. We are trying to get a regular manufacture that isn't interested in getting registered. So where do we go with it?

Any suggestions would be much appreciated!
Thanks,
Alex Bock

Hi Alex,

I understand that it might be a little overwhelming for first timers but actually it's quite simple in terms of FDA expectations and what you should or shouldn't do. Component manufacturers are not routinely overseen by FDA, especially where device intended use is straightforward and low-risk. On the other hand, some single entity has to be accountable to the FDA, either you (the legal manufacturer) or a contract manufacturer. In some cases 2 or 3 entities might take on that role in a coordinated, shared manner, but that's normally when a complicated system is at hand. Not in your case.

Your options are either source all the components from non-registered manufacturers and do the assembly in house, registering as the manufacturer; or engage a contract manufacturer who's already registered as such and will (optionally) source the components from their supply chain; or find a non-registered contract manufacturer who's willing to register. You won't be allowed to source a finished product (minus battery) from a single manufacturer who's not registered and not willing to register.

The key is someone needs to be accountable to the FDA over manufacturing a finished device. Inserting a battery does not - in my opinion - constitute manufacturing a finished device out of components. Usually retail packaging of finished devices supplied in wholesale packaging also doesn't qualify for that purpose.

Regards,
Ronen.

 

[Julie O]

We are a Class II device.

We are also GMP exempt.

I'm curious to know how you established that the device is Class II and GMP exempt?

 

[Debra]

I'm curious to know how you established that the device is Class II and GMP exempt?

Julie is right...the very fact that you are submitting a 510(K) you are saying you are a manufacturer introducing a device into the market. All medical devices must follow the QSR's from CFR Part 820. The quality system must be planned, developed and implemented.