ALLYSON B. MULLEN is a director in the Washington, DC office of Hyman, Phelps & McNamara, P.C. where she provides counsel to medical device and in vitro diagnostic (IVD) manufacturers. Ms. Mullen assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. In the premarket area, Ms. Mullen prepares IDEs, 510(k)s, de novos, and PMAs. She also prepares pre-submissions, breakthrough device designation requests, and assists clients in preparing for and represents clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, advertising and promotion, and QSR compliance. Ms. Mullen also helps clients with contract matters and regulatory due diligence. Prior to joining the firm in 2013, Ms. Mullen worked as in-house counsel at Waters Corporation, an IVD company. In this role, Ms. Mullen conducted a range of legal and regulatory functions.