Traditional 510K Submission-Financial Certification or Disclosure Statement

[Nomad.David]

Hi everybody, hope you are doing well. I am new in this platform. I am trying to prepare traditional 510k submission/class II for pregnancy test (cassette and midstream), I am quite confused while I prepare documents.

When it comes to Financial Certification and Disclosure Statement, FDA document (Format for Traditional and Abbreviated 510(k)s ) stated that ".....you must submit a financial certification and/or a disclosure statement for each clinical investigator who participated in your study..."

What does "clinical investigator" exactly mean in above sentence? Do I have to list the names of the all women who participate in the studies or something else?

I do appreciate, if anyone let me know.

Thanks in advance.

 

[mihzago]

Study participants are not clinical investigators, they are simply subjects.
Each study has at least one Principal Investigator. Depending on how many sites there are and how they are set up, there may be several PIs. For example, if you have a study at 3 different unaffiliated clinics, there will likely be 3 PIs. If you have a study in a hospital system with subjects reporting to several local affiliated offices, you may only have 1PI that oversees these sites. Your IRB protocol and study plan should identify how many sites and who are the PIs.
The fda form is requiring you to list all PI involved in the study.

If your company is sponsoring and running a study (i.e., collect data from subjects) you are called a sponsor-investigator and in that case you too should have an individual designated as a PI.

 

[monoj mon]

Hi everybody, hope you are doing well. I am new in this platform. I am trying to prepare traditional 510k submission/class II for pregnancy test (cassette and midstream), I am quite confused while I prepare documents.

When it comes to Financial Certification and Disclosure Statement, FDA document (Format for Traditional and Abbreviated 510(k)s ) stated that ".....you must submit a financial certification and/or a disclosure statement for each clinical investigator who participated in your study..."

What does "clinical investigator" exactly mean in above sentence? Do I have to list the names of the all women who participate in the studies or something else?

I do appreciate, if anyone let me know.

Thanks in advance.

Does your submission include any clinical data in order to prove safety and efficacy of your device! If not, then you don't need to bother about that statement. You can simply state that this section is not applicable. If you have clinical data, then follow @mihzago's advice.

 

[Nomad.David]

Study participants are not clinical investigators, they are simply subjects.
Each study has at least one Principal Investigator. Depending on how many sites there are and how they are set up, there may be several PIs. For example, if you have a study at 3 different unaffiliated clinics, there will likely be 3 PIs. If you have a study in a hospital system with subjects reporting to several local affiliated offices, you may only have 1PI that oversees these sites. Your IRB protocol and study plan should identify how many sites and who are the PIs.
The fda form is requiring you to list all PI involved in the study.

If your company is sponsoring and running a study (i.e., collect data from subjects) you are called a sponsor-investigator and in that case you too should have an individual designated as a PI.

Thank you very much!

 

[Nomad.David]

Study participants are not clinical investigators, they are simply subjects.
Each study has at least one Principal Investigator. Depending on how many sites there are and how they are set up, there may be several PIs. For example, if you have a study at 3 different unaffiliated clinics, there will likely be 3 PIs. If you have a study in a hospital system with subjects reporting to several local affiliated offices, you may only have 1PI that oversees these sites. Your IRB protocol and study plan should identify how many sites and who are the PIs.
The fda form is requiring you to list all PI involved in the study.

If your company is sponsoring and running a study (i.e., collect data from subjects) you are called a sponsor-investigator and in that case you too should have an individual designated as a PI.

Hi Mihazo, I want to ask a one more question. Our company will be the initial importer (private labeler) of the pregnancy tests. Our manufacturer is not keen to share the details of the clinical studies. (By the way, tests have CE marking and selling in European Economic Zone.)

As far as I understand, only option I can mark in the attached document (Certification-Financial Interest and Arrangements of Clinical Investigator) is 3rd one. Could you give me any advice on reason why the information could not obtain?

 

[mihzago]

I'm not fully understanding something. In the original email you said that you're preparing a 510(k). In the last email that you are an Initial Importer.
Initial importers typically do not submit 510(k)s, but if for some reason you are submitting a 510(k) on behalf of the foreign manufacturer, or on your own but with their data, you need a full access to the clinical and all other performance data because you have to submit this information with your 510(k) application.

I'm not sure what your relationship with the foreign manufacturer is, but you if you become the owner of the 510(k) then you'll probably have to register as manufacturer or specification developer.

Yet another issue you may run into is that OUS (outside of US) clinical investigations are not readily accepted by the FDA.

 

[Nomad.David]

We are planning to import the devices and repackaging/relabeling in here. Without 510k clearance, we could not import components of the product particularly finished cassettes/midstreams (FDA officials gave me this info).