Certificate of Need (CON) and FDA Requirements

Sue789

Involved In Discussions
#1
I am a UK start-up company in the early stages of designing an electro/mechanical medical device and do not expect to complete clinical trials until 2018.

An employee is in the process of negating a sale with a DoH that require a Certificate of Need (CON) to be completed and one of the requirements that I have been given is I must be in contact with the FDA so he can complete his application.As a Company with no products on the marketplace and a class II device I had no intention of involving the FDA until the testing had been completed.

Can anybody put any light on what contact with the FDA I need to satisfy the DoH CON or where I can find this information?

I have looked on the relevant DoH website and could not find anything to help me.

Thank you in advance.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
I am a UK start-up company in the early stages of designing an electro/mechanical medical device and do not expect to complete clinical trials until 2018.

An employee is in the process of negating a sale with a DoH that require a Certificate of Need (CON) to be completed and one of the requirements that I have been given is I must be in contact with the FDA so he can complete his application.As a Company with no products on the marketplace and a class II device I had no intention of involving the FDA until the testing had been completed.

Can anybody put any light on what contact with the FDA I need to satisfy the DoH CON or where I can find this information?

I have looked on the relevant DoH website and could not find anything to help me.

Thank you in advance.
Hi,

I assume that the employee is in the process of negotiating a sale, not of negating it...

It would assist if you could clarify what country/state you refer to when mentioning the DoH, i.e. the DoH of what country/state.

one of the requirements that I have been given is I must be in contact with the FDA so he can complete his application
Who gave you this requirement?
What sort of "contact" is required with the FDA? Was a certain process or documentation that the FDA runs called out?
Who is "he" in "he can complete his application"?

Being successful in QA / regulatory affairs is many times about being clear and precise.

Cheers,
Ronen.
 
Last edited:
M

MIREGMGR

#3
Some USA states, in order to manage healthcare patient capacity and therefore healthcare costs, won't allow care facilities to buy capital equipment without issuance by the state's Health Department or similar state regulatory body of a Certificate of Need (CON).

In some states...all that I know of with such a system, actually...a CON won't be issued for a device for which the marketer cannot show completion of US FDA regulatory requirements for legal marketing. I don't understand how your prospective buyer expects a CON to be obtained, unless he or she doesn't yet understand that the device is still in clinicals and isn't yet legally marketable.

A comprehensive explanation of the US CON system is at http://www.ncsl.org/research/health/con-certificate-of-need-state-laws.aspx.

In some instances, a US institution with an IRB can obtain a system for which an IDE has been obtained without a CON by obtaining an IRB exception. Normally, though, this must be done at whatever price can be negotiated without the buyer being eligible for reimbursement for procedures done on the IDE equipment until it becomes legally marketable and the CON is applied for and (the buyer hopes) granted.
 
Last edited by a moderator:

somashekar

Staff member
Super Moderator
#4
I am a UK start-up company in the early stages of designing an electro/mechanical medical device and do not expect to complete clinical trials until 2018.

An employee is in the process of negating a sale with a DoH that require a Certificate of Need (CON) to be completed and one of the requirements that I have been given is I must be in contact with the FDA so he can complete his application.As a Company with no products on the marketplace and a class II device I had no intention of involving the FDA until the testing had been completed.

Can anybody put any light on what contact with the FDA I need to satisfy the DoH CON or where I can find this information?

I have looked on the relevant DoH website and could not find anything to help me.

Thank you in advance.
All that I can see is that you have to get the 510k for your medical device, and inform that to whoever is negating a sale.
 

Sue789

Involved In Discussions
#5
Hi All,

Thank you very much for your quick responses, the state in question is New York and this is as far as I am aware the first time the employee has been involved in a tender in the USA. There is a money incentive but not sure what it is only that part of it we have to have a manufacturing facility in New York state.
The requirement came from the employee and I am waiting detailed information from his contact and have requested the wording that I have to comply with.

‘a CON won't be issued for a device for which the marketer cannot show completion of US FDA regulatory requirements for legal marketing. I don't understand how your prospective buyer expects a CON to be obtained, unless he or she doesn't yet understand that the device is still in clinicals and isn't yet legally marketable.’

The employee is very aware that the device has not been built and is very keen for a sale in New York; I have no project documentation available (not even requirement specifications!). A previous employee who is no longer with the Company had said that they would contact the FDA during 2014 and go the route of a Pre-Submission. I put a stop to this as in my experience a class II device a 510(k) will be sufficient and a Pre-Submission is not necessary.
Miregmgr thanks for the link I will investigate.
 
Last edited:

mihzago

Trusted Information Resource
#7
you cannot offer a medical device for sale that has not been cleared or approved by the FDA; so negotiating a sale is against the regulations.
You cannot claim safety and performance of a device that does not have a clearance/approval.

This is also one of the reasons as a few people mentioned earlier that you cannot get the CON.

Unless the "sale" is for the clinical trial purposes, but that raises a serious question/issue of bias.
 
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