[Patentcenter] FDA CONSULTANT recommendation needed

[E. Victor Indiano]

Dear List Mates--

I have an Italian client who is introducing a medical software product into the United States. As I understand that such software needs to be approved by the FDA, he needs an FDA consultant.

I am reasonably sure that the approval will be a 510K approval rather than a new drug app.  I also believe that the consultant need not be a lawyer, as many in the medical device profession regularly do FDA consulting.

Does anyone have any recommendations for such a consultant that they would be willing to share?

Thanks in advance for your help.

Vic Indiano


The Indiano Law Group, LLC

E. Victor Indiano
9795 Crosspoint Blvd. Suite 185
Indianapolis, IN 46256
Direct Phone:317-927-8465
E-Mail Vic at IM-iplaw.com<mailto:Vic at IM-iplaw.com>
www.indyiplaw.com<http://www.indyiplaw.com/>
www.im-iplaw.com<http://www.im-iplaw.com/>

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