Allyson B. Mullen

Allyson Mullen 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 develops regulatory strategy, including obtaining breakthrough device designation and preparing pre-submissions to obtain FDA feedback. She also assists clients in understanding FDA’s pre-submission feedback in an effort to prepare for and represents clients at pre-submission meetings with FDA. She also assists with preparing premarket submissions, including IDEs, 510(k)s, de novos, and PMAs. As part of this process, she assists clients in responding to FDA additional information requests during premarket review with a view toward fully understanding and addressing FDA concerns at the earliest possible time. She also represents clients on medical device appeals within FDA, including those relating to deficiencies raised in premarket responses from FDA (e.g., NSE letters, de novo denials). In the postmarket area, she advises clients on regulatory compliance matters, including complaint handling, MDRs, field actions, promotional review, 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.