Can a consultant outside of the USA be a contact person on 510k?

Hi Everyone
Our company is submitting a 510k for a class II software used in medical devices. We hired a consultant who trained our organization about certain FDA regulations and went through all our design and other regulatory documents and provided us reviews.

Now the consultant wants his name as the contact person in 510k, but the consultant does not reside in USA. Can I write his name in the contact person? Please advise.

Jennifer27 said:

Hi Everyone
Our company is submitting a 510k for a class II software used in medical devices. We hired a consultant who trained our organization about certain FDA regulations and went through all our design and other regulatory documents and provided us reviews.

Now the consultant wants his name as the contact person in 510k, but the consultant does not reside in USA. Can I write his name in the contact person? Please advise.

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Hi,

From my experience, there is no problem with that when the manufacturer (510k owner) is also outside the USA; However, I wasn't yet named as the 510k contact person for a 510k owner in the USA...

Cheers,
Ronen.

The contact person does not have to be resident in the US.

The contact person is one who the FDA will correspond with during the review process. Yes you can use the consultant, if he will be available as a contact.

Did your consultant advise you on this?

The US Agent MUST have an address in the USA. But the US Agent doesn't have to be the contact person. The contact person can therefore be outside of the US.

It will actually mostly be the case for foreign manufacturers. It can be a consultant or someone in the RA department who is in charge of the application. The contact person will receive the correspondence, eventually, the Request for Additional Information. It is the preson that the reviewer will contact should any question about the application arise.

Hi Ronen,
May I know the reason why you were not named as the 510k contact person?
Our company too is in USA and our consultant is outside USA.

Hi Joanne, The consultant said that he could correspond but my boss wanted me get some more opinions, may be he had some doubts. I'm not sure.

Jennifer27 said:

Hi Ronen,
May I know the reason why you were not named as the 510k contact person?
Our company too is in USA and our consultant is outside USA.

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Hi Jennifer,

I simply didn't yet have the honour of preparing a 510(k) submission for a USA-based company, though I did consult some on other matters. I reside outside the USA, and I guess most companies prefer to have their consultants near by.

As there are many competent USA-based medical devices consultants, I wonder what would cause a company to hire a foreign consultant. My experience in consulting USA-based companies involved very narrow expertise, which they could not easily source inside the USA. Is your case similar?

Cheers,
Ronen.

Refer Foreign Manufacturers -

Foreign Manufacturers
Can foreign companies submit a Premarket Notification 510(k)?

Yes. The foreign manufacturer may submit a 510(k) directly to FDA. For convenience, a foreign manufacturer may receive assistance from a U.S. entity and may use a contact person residing in the U.S.

You are right Ronen. In our case -- We are a small business and we had budget limitations. This consultant is actually a Biomedical engineer and a certified regulatory professional but he is too young only 26, hence has limited experience.

We hired him because he had good knowledge of regulations and he offered to do the 510k for us in just 1000USD. He did training sessions for us, we prepared the 510k documents and he just reviewed all our 510k submission documents and commented on them. He did several rounds of revision for us, as we are new to regulatory. He particularly helped us with FMEA and risk assessment and compliance. He is soon going to move to US.

He said he did this for us at a tremendously reduced price and hence he wanted his name as a contact person, so he could use that 510k as a reference. But he said at this point of time experience was more important for him as he was trying to start his career s a consultant along with working full time.

For the kind of job that he did for us and for a consultant with just 1-2 yrs of experience, what price do you know is currently in?

Jennifer27 said:

You are right Ronen. In our case -- We are a small business and we had budget limitations. This consultant is actually a Biomedical engineer and a certified regulatory professional but he is too young only 26, hence has limited experience.

We hired him because he had good knowledge of regulations and he offered to do the 510k for us in just 1000USD. He did training sessions for us, we prepared the 510k documents and he just reviewed all our 510k submission documents and commented on them. He did several rounds of revision for us, as we are new to regulatory. He particularly helped us with FMEA and risk assessment and compliance. He is soon going to move to US.

He said he did this for us at a tremendously reduced price and hence he wanted his name as a contact person, so he could use that 510k as a reference. But he said at this point of time experience was more important for him as he was trying to start his career s a consultant along with working full time.

For the kind of job that he did for us and for a consultant with just 1-2 yrs of experience, what price do you know is currently in?

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Hi Jennifer,

First, for the scope you described $1,000 is indeed cheap, assuming he did a good job and will not fail you out of lack of experience. It was mentioned here in the past that there is to working with the FDA more than knowing and understanding the formal regulation, because sometimes there are unwritten or informal policies / trends among FDA reviewers & auditors, and you have to be involved over time to get a good feel of what will fly and what won't. MIREGMGR provided some eye opening examples in the past.

To your last question - I don't know of any common "list prices" or benchmark for this kind of jobs. I don't have my own list prices either. I provide my quotes on a tailored case-by-case basis. I take the time to study the case - manufacturer and product, then work the arrangement details a bit with the potential client, until the major aspects are configured (scope, work mechanism, schedule etc.) and then I provide the quote, which can go through several revisions before a PO is issued. As a general comment I think anything under $5,000US for the full preparation of a straightforward traditional 510(k) is cheap, but as I explained before it actually requires studying the details to make a more concrete statement.

Cheers,
Ronen.

PS In my opinion a consultant doesn't need his/her name on the submission (as a contact person) to get credit for it. they could state that they did this-and-that, and provide your company's contact details (with your permission of course) for reference. Moreover, the fact that a person is named as the contact person does not "prove" the they were the ones who prepared the 510(k).