MDC Associates, Inc.

• Develop, compile, review, and submit FDA premarket submissions including 510(k), De Novo, and Pre-Market Approval (PMA) applications • Prepare and submit FDA Q-Submissions including Pre-Submissions, Breakthrough Device Designation Requests, and Submission Issue Requests • Identify appropriate regulatory pathways for new IVDs and conduct predicate device comparisons • Design analytical and clinical studies in accordance with FDA guidance documents, predicate device comparisons, and regulatory communications—with specific experience in AST diagnostic studies • Act as lead correspondent with FDA throughout the submission and review process • Create Clinical Study Protocols, Statistical Analysis Plans, Manuals of Procedures, and other clinical study documentation • Prepare Clinical Study Reports with results analysis suitable for FDA submission • Assist clients in identifying and contracting with Clinical Trial Sites and/or Reference Laboratories • Assist with Institutional Review Board (IRB) submissions • Review software and cybersecurity documentation for FDA premarket submissions • Provide regulatory guidance and strategic input to IVD medical device manufacturers throughout product development