Allyson B. Mullen
J.D., magna cum laude, New England School of Law
B.S., Biochemistry, Worcester Polytechnic Institute
District of Columbia
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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.
• 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).
Articles / Publications
see more articles
• Devices May Be Over-the-Hill, but Regulatory Developments and Challenges Show No Signs of Slowing Down,
July 12, 2016
• 510(k) Statistical Patterns,
December 2, 2014
• FDA's Move to Regulate LDTs Could Reshape the Industry,
September 19, 2014
• 4 Regulatory Challenges Facing IVD Companies Today,
May 12, 2014
• How to Effectively Use FDA's Presubmission Process,
May 12, 2014
• 21st Century Cures Act and its Effect on FDA’s Regulation of Devices and Combination Products, January 18, 2017
• 2014 ABA Regional Pharmaceutical and Medical Device Regional CLE Seminar, Allyson Mullen will be speaking on a panel at the 2014 ABA Regional Pharmaceutical and Medical Device Regional CLE Seminar., October 9, 2014
• Device Off-Label Promotion Squarely On FDA's Radar Screen, November 12, 2013
• FDLI: Introduction to Medical Device Law and Regulation - The Legal Framework for Medical Device Regulation, Post Market Issues, October 8 - 9, 2013
see more blog entries
• FDA Issues Proposed List of Class II Devices for 510(k) Exemption – Focus on IVDs, Including Drugs-of-Abuse Tests,
March 15, 2017
• No Final LDT Guidance, But FDA Provides Insight into What a Future Guidance Might Contain,
January 26, 2017
• CDRH Finalizes Post-Market Cybersecurity Guidance,
January 4, 2017
• CDRH Finalizes Benefit-Risk Factors in Making Compliance and Enforcement Decisions Guidance,
December 29, 2016
• FDA Finalizes Guidance for Notifying the Public of Emerging Postmarket Medical Device Signals,
December 26, 2016