Steven J. Gonzalez Associate 202-800-3511
Steven J. Gonzalez
Practice Areas
Industries
FDA Regulatory Categories

Overview

Steven focuses his practice on counseling medical device and in vitro diagnostic manufacturers on a broad range of pre- and post-market regulatory and compliance issues under the Food, Drug, and Cosmetic Act and related laws, including product development and marketing authorization, advertising and promotion, and inspection and enforcement matters.

Pre-market, Steven develops regulatory strategy, assists with pre-submission requests and meetings with FDA, and prepares premarket submissions, including IDEs, 510(k)s, de novos, and PMAs. He helps clients respond to FDA requests for additional information during premarket review and with administrative appeals to FDA for adverse regulatory decisions (e.g., NSE letters or de novo denials).

Post-market, Steven advises clients on issues related to complaint handling, Medical Device Reporting, field actions/recalls, promotional review, and the Quality System Regulation. He provides strategic advice and drafts company responses to FDA-483 inspection observations and warning/untitled letters.

Steven also routinely provides regulatory counsel for corporate transactions, license and collaboration agreements, manufacturing and supply arrangements, and public and private securities offerings involving drug, device, cosmetic, food, and dietary supplement companies.

Education & Admissions

Education

  • J.D., Harvard Law School, 2017; Executive Editor, Harvard Law and Policy Review
  • B.A., University of California, Santa Barbara, 2012, Cum Laude

Admissions

California (voluntary inactive)
District of Columbia

Experience

  • Provide FDA regulatory assessment memoranda for medical devices, including both Hardware and Software as a Medical Device (SaMD) products such as Clinical Decision Support, Medical Device Data Storage, Mobile Medical Applications, General Wellness products.
  • Regularly assist medical device companies with FDA premarket communications, including drafting pre-submission meeting requests, pre-requests for designation of combination products, 513(g) requests for classification of devices, and EUA, 510(k), de novo, or premarket approval applications.
  • Draft and present administrative appeals of FDA denials of 510(k) applications.
  • Advise on responses to FDA Warning and Untitled Letters to medical device companies.
  • Assist companies with postmarket activities, including determinations, reporting and communications with customers regarding recalls and medical device reporting.
  • Respond to and draft trade complaints from or to competitor medical device companies alleging regulatory violations.
  • Conduct review of advertising and promotional materials for medical device companies.
  • Perform FDA due diligence for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies and other acquisitions and investments in FDA-regulated firms on behalf of both private equity and strategic buyers.
  • Counsel companies regarding informed consent, IBR approval, and IDE requirements for clinical research.
  • Draft commercial regulatory contracts, including supply, distribution, laboratory services, and quality agreements.

 

Speaking Engagements

  • Speaker, AMDM’s 2025 Annual IVD Regulatory Meeting, LDT Final Ruling – What’s Next and Where do We go From Here, April 30-May 1, 2025
  • Panelist, GRx + Biosims Conference, Legal Overview of the Biosecure Act, October 2024
  • Presenter, FDLI/CDRH In-House Training, Product Problems/Adverse Events, November 2023, September 2023, and May 2024
  • Lecturer, George Washington University, BME 6481 – Regulatory Law for Medical Devices, Spring 2023.
Education
  • J.D., Harvard Law School, 2017; Executive Editor, Harvard Law and Policy Review
  • B.A., University of California, Santa Barbara, 2012, Cum Laude
Admissions

California (voluntary inactive)
District of Columbia

Practice Areas
Industries
FDA Regulatory Categories