Adrienne R. Lenz Principal Device Regulatory Expert 202-737-4292
Adrienne R. Lenz

Overview

Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz 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. Lenz 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 design controls, risk management, MDRs, field actions, and QSR compliance. Ms. Lenz also helps clients with quality system audits and regulatory due diligence.

Prior to joining the firm in 2017, Ms. Lenz worked as an independent regulatory consultant and consultant with Emergo.  She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.  In these roles, Ms. Lenz conducted a range of regulatory, quality, and engineering functions working with medical device companies and development teams of all sizes in the US, Europe and Asia.

Industries

Education & Admissions

Education

M.S., Physiology, Medical College of Wisconsin
B.S., Biomedical Engineering, Milwaukee School of Engineering

Admissions

RAC-US
Regulatory Affairs Professional Society

Experience

  • Prepares and reviews product submissions, including, 510(k)s, de novos, PMAs,  IDEs, and Pre-Submissions.
  • Assists 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 design control, testing and risk management.
  • Advises on MDRs and complaint handling, recalls, corrections, and removals.
  • Advises on enforcement actions, including, 483s and warning letters.
  • Prepares regulatory procedures (e.g., design control, risk management).
  • Reviews promotional material and labeling.
  • Performs regulatory due diligence for mergers and acquisitions.
  •  Assists companies with Quality System Regulation (QSR) matters.

Speaking Engagements

  • RAPS Convergence 2024, FDA’s Total Product Life Cycle Advisory Program (TAP) pilot, September 17-19, 2024
  • IVD Clinical & Regulatory Affairs Conference, Understanding the Impact of Recent Software Development and Cybersecurity Rules, May 21-22, 2024
  • RAPS Euro Convergence 2024, Patient-Centric Endpoints and Use of Digital Health Technologies, May 6-8, 2024
  • RAPS Convergence 2022, Combination Products-Perspectives from Drug/Biologics and Device Industries, September 11-13, 2022
  • Life Science Regulatory Intelligence Conference (Virtual Event), Deciphering New & Proposed Regulatory Guidances for Medical Device & Diagnostics, January 24-25, 2022
  • RAPS Wisconsin Chapter Webcast: Device Requirements for Drug-Led Combinations, June 23, 2021
  • CTel Digital Health Summit, Get to Know FDA’s Digital Health Center of Excellence, June 9-11, 2021
  • RAPS Wisconsin Chapter Webcast: Regulatory Regime Change for Drugs and Devices in the UK Post-Brexit (introducing speaker), January 13, 2021
  • RAPS Regulatory Convergence, 510(k):  Deciding When to Submit a Change to an Existing Device, Oct 1-4, 2018
  • RAPS Chicago Chapter, 510(k) Basics and Beyond, July 26, 2018
  • RAPS Twin Cities Chapter, Modifications 510(k): Deciding When to Submit for a Change to an Existing Device, March 29, 2018
  • RAPS Wisconsin Chapter Presentation and Roundtable Discussion, 510(k) Basics and Beyond, March 13, 2018
Education

M.S., Physiology, Medical College of Wisconsin
B.S., Biomedical Engineering, Milwaukee School of Engineering

Admissions

RAC-US
Regulatory Affairs Professional Society

Practice Areas
Industries
FDA Regulatory Categories