Medical Device Licensing - Plans or Process Maps

[Aaria]

I am new to the local/state regulations (US) for medical device licensing. Reading other threads helped, but couldn't get a comprehensive snapshot of requirements. The product I am working with is a wearable drug delivery system which does not have any drug products built in and is indicated to use an already approved drug with a separate prescription. We are trying to come up with a plan for commercializing in US and licensing requirements is one of them.

Has anyone compiled a medical device licensing plan or have process maps/procedures that could be shared? I am also interested in learning more about everyone's learning experience in this process (Do's and Don'ts).

Thanks for your time.

 

[Ronen E]

I am new to the local/state regulations (US) for medical device licensing. Reading other threads helped, but couldn't get a comprehensive snapshot of requirements. The product I am working with is a wearable drug delivery system which does not have any drug products built in and is indicated to use an already approved drug with a separate prescription. We are trying to come up with a plan for commercializing in US and licensing requirements is one of them.

Has anyone compiled a medical device licensing plan or have process maps/procedures that could be shared? I am also interested in learning more about everyone's learning experience in this process (Do's and Don'ts).

Thanks for your time.

Hi,

Just to clarify, when you refer to "licensing", do you mean that your commercialization will consist of selling licenses to other companies to use your design (is it already cleared with the FDA?) to actually make the device and distribute it under their name? Will your company be one of the actual manufacturers, too?

My impression is that US state medical devices regulations vary, so your plan should address the target states individually.

Cheers,
Ronen.

 

[Aaria]

Thanks for your response Ronen. We actually will be sole manufacturer and potential selling through distributor-pharmacy chain model. Since in most cases pharmacy will be dispensing our device per physician prescription, we may be subject to US state registration/licensing requirements.

Should we be always visiting state board of pharmacy for registration/licensing requirements? Any resources you could point to?

Thanks,
Pooja

 

[Ronen E]

Thanks for your response Ronen. We actually will be sole manufacturer and potential selling through distributor-pharmacy chain model. Since in most cases pharmacy will be dispensing our device per physician prescription, we may be subject to US state registration/licensing requirements.

Should we be always visiting state board of pharmacy for registration/licensing requirements? Any resources you could point to?

Thanks,
Pooja

Thanks for clarifying and sorry for me being thick... My mind was stuck on commercial licensing so I didn't realize you were talking about pharmacy dispensing related state licensing...

Using the Google search box (within Elsmar) at the top left hand corner, with search terms such as "state", "licensing", "prescription" etc., seems to yield quite a few relevant threads. As I noted above, state regulations vary, so perhaps also use the state name - it might have been explicitly brought up.

Cheers,
Ronen.