Allyson B. Mullen Associate 202-737-9639
Allyson B. Mullen

Overview

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 prepares IDEs, 510(k)s, de novos, and PMAs. She also prepares pre-submissions, 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, 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.

Education & Admissions

Education

J.D., magna cum laude, New England School of Law
B.S., Biochemistry, Worcester Polytechnic Institute

Admissions

District of Columbia
Massachusetts

Experience

Medical Devices

  • Prepares and reviews product submissions, including, 510(k)s, IDEs, and Pre-Submissions.
  • Counsels clients in responding to FDA deficiency letters and requests for additional information.
  • Evaluates and develops regulatory and marketing strategies.
  • Assists with determining regulatory requirements for product modifications, including design, supplier, and manufacturing changes.
  • Advises on MDRs and complaint handling, recalls, corrections, and removals.
  • Advises on enforcement actions, including, 483s and warning letters.
  • Prepares regulatory procedures (e.g., complaint handling, MDR, recalls).
  • Reviews promotional material and labeling.
  • Performs regulatory due diligence for mergers and acquisitions.
  • Assists companies with Quality System Regulation (QSR) matters.

In Vitro Diagnostic Devices

  • Helps clients develop regulatory strategies for clearance and approval.
  • Provides guidance on Laboratory Developed Tests (LDTs).
  • Provides advice on requirements for RUO assays and instruments.
  • Assists with post-market compliance.

Corporate Policies and Compliance Matters

  • Prepares and advises on corporate policies and compliance matters.
  • Drafts and reviews contracts related to various regulated matters (e.g., distributor agreements, supplier agreements).

Recent Speaking Engagements

  • AMDM IVD Focus Meeting, How to Comment on FDA Guidance Documents, October 5-6, 2017
Education

J.D., magna cum laude, New England School of Law
B.S., Biochemistry, Worcester Polytechnic Institute

Admissions

District of Columbia
Massachusetts

Practice Areas
Industries
FDA Regulatory Categories