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<p class="MsoNormal">Dear List Mates--</p>
<p><span style="font-family:"Arial",sans-serif">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.<o:p></o:p></span></p>
<p><span style="font-family:"Arial",sans-serif">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.<o:p></o:p></span></p>
<p><span style="font-family:"Arial",sans-serif">Does anyone have any recommendations for such a consultant that they would be willing to share?<o:p></o:p></span></p>
<p><span style="font-family:"Arial",sans-serif">Thanks in advance for your help.<o:p></o:p></span></p>
<p><span style="font-family:"Arial",sans-serif">Vic Indiano<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span style="font-size:16.0pt;font-family:"Arial Black",sans-serif;color:black">The Indiano Law Group, LLC<o:p></o:p></span></p>
<p class="MsoNormal" style="background:white"><b><span style="font-size:16.0pt;font-family:"Helvetica",sans-serif;color:black"><o:p> </o:p></span></b></p>
<p class="MsoNormal" style="background:white"><b><span style="font-size:16.0pt;font-family:"Helvetica",sans-serif;color:black">E. Victor Indiano</span></b><b><span style="font-size:16.0pt;font-family:"Helvetica",sans-serif;color:black;mso-ligatures:none"><o:p></o:p></span></b></p>
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<p class="MsoNormal" style="background:white"><span style="font-size:14.0pt;font-family:"Helvetica",sans-serif;color:black">9795 Crosspoint Blvd. Suite 185<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span style="font-size:14.0pt;font-family:"Helvetica",sans-serif;color:black">Indianapolis, IN 46256<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span style="font-size:14.0pt;font-family:"Helvetica",sans-serif;color:black">Direct Phone:317-927-8465<o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span lang="DE" style="font-size:14.0pt;font-family:"Helvetica",sans-serif;color:black">E-Mail
<a href="mailto:Vic@IM-iplaw.com">Vic@IM-iplaw.com</a> <o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span style="font-size:14.0pt;font-family:"Helvetica",sans-serif;color:black"><a href="http://www.indyiplaw.com/"><span lang="DE">www.indyiplaw.com</span></a></span><span lang="DE" style="font-size:14.0pt;font-family:"Helvetica",sans-serif;color:black"> <o:p></o:p></span></p>
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<p class="MsoNormal" style="background:white"><span style="font-size:14.0pt;font-family:"Helvetica",sans-serif;color:black"><a href="http://www.im-iplaw.com/"><span lang="DE">www.im-iplaw.com</span></a></span><span lang="DE" style="font-size:12.0pt;color:black"> </span><span lang="DE"><o:p></o:p></span></p>
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