Allyson B. Mullen Director 202-737-9639
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.

Education & Admissions


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


District of Columbia


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).

Honors & Awards

  • Best Lawyers, 2024

Speaking Engagements

  • AMDM’s 2023 IVD Hybrid Focus Meeting, Industry Update, October 19-20, 2023
  • SAGES 16th International NOSCAR Summit  and Surgical Disruptive Technology Summit, FDA Panel Discussion, June 9-11, 2022
  • AMCP eLearning Days, Prescription Digital Therapeutics: Regulatory Approval Pathway and Outcomes Evidence, May 11, 2022
  • AMDM 2022 Annual IVD Regulatory Meeting, Compliance Hot Topics, April 27, 2022
  • AMDM Virtual Focus Meeting, ISO 13485/CFR 820 Hamonization Efforts, October 8, 2021
  • RAPS Convergence Pre-Conference Workshop, Strategies for Products With More Than One Product Type, September 10, 2021
  • AMDM Annual IVD Regulatory Meeting, Challenges and Opportunities
    for (non-COVID) Diagnostics in the Time of COVID-19, April 16, 2021
  • AMDM IVD Focus Meeting, Industry Update/Industry Perspective, October 3, 2019
  • Association of Medical Diagnostic Manufacturers’ Annual Meeting and OIR 510k Submissions Workshops, April 8-11, 2019
  • FDLI Advertising and Promotion Conference for the Drug, Medical Device, and Veterinary Industries, Medical Devices and IVDs: Regulatory Challenges of Advertising and Promotion, October 16-17, 2018
  • Association of Medical Diagnostics Manufacturers 2018 Focus Group Meeting, IVD Industry Update/Industry Perspective, October 11-12, 2018
  • ACI Summit on Digital Health Law, Reviewing the Influence and Future of Blockchain, July 19-20, 2018
  • Association of Medical Diagnostics Manufacturers Annual Meeting, Top 10 FDA Guidances from 2017 for IVD Companies, April 18-19, 2018
  • Food and Drug Law Institute Introduction to US Medical Device Law and Regulation Conference, Manufacturing and Quality System Regulation, April 12-13, 2018
  • AMDM IVD Focus Meeting, How to Comment on FDA Guidance Documents, October 5-6, 2017
  • Webinar, Medical Device: The FDA’s Role in Your Case, September 12, 2017

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


District of Columbia

Practice Areas
FDA Regulatory Categories