Richard A. Lewis, Ph.D. Senior Regulatory Device & Biologics Expert
Richard A. Lewis, Ph.D.
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FDA Regulatory Categories

Overview

Dr. Lewis started his FDA career in CDRH’s Division of Chemistry and Toxicology Devices in the Office of In-Vitro Diagnostics and Radiological Health working on pre-market review and post-market compliance for diagnostic devices.  The day-to-day activity included the review of 510(k)s, PMAs, IDEs, Pre-Submissions, 483s, Warning Letters, It Has Come to Our Attention Letters, Recalls, MDRs, and Import Alerts.

Dr. Lewis moved from the medical device space to biologics with CBER’s Division of Manufacturing and Product Quality in the Office of Compliance and Biologics Quality working on manufacturing reviews and conducting pre-license inspections for BLAs. During his tenure in CBER, Dr. Lewis served as the principal advisor for all device submissions in Manufacturing Review Branch II.

Dr. Lewis has eight years of experience conducting cutting edge research synthesizing new molecules under oxygen and moisture sensitive conditions. He is versed in analytical techniques including: Single Crystal X-Ray Diffraction, SQUID Magnetometry, Mossbauer Spectroscopy, Electrochemistry, NMR Spectroscopy, IR Spectroscopy, UV-Vis Spectroscopy, and GC/MS.

Education & Admissions

Education

B.S., Chemistry, University of California San Diego
Ph.D., Chemistry, University of California Santa Barbara
Post-Doctoral, Yale University

Experience

  • Participated in multiple FDA inspections of manufacturing facilities as part of the licensing process for BLAs concerning new devices and vaccines (21 CFR 211, 600, and 820).
  • Evaluated facility design, operation, manufacturing/testing procedures for compliance with Good Manufacturing Practices (GMPs).
  • Reviewed validation activities for manufacturing equipment and facilities.
  • Experienced in investigations and CAPAs.
  • Reviewed Investigational Device Exemptions (IDEs) for new and breakthrough devices to ensure the safety of the patients in the study.
  • Reviewed product submissions, including, 510(k)s, PMAs, BLAs, IDEs, Type B/C Meetings, and Pre-Submissions.
  • Participated in a wide range of FDA enforcement actions including 483s, It Has Come to Our Attention Letters, Untitled Letters, Warning Letters, and Import Alerts.
  • Experienced in the review and classification of MDRs and Recalls.
  • Experienced in the regulation of RUO, FUO, and LDT Products.

Honors & Awards

  • CDRH Process Improvement Award DCTD 30-Day Notice Team, 2018
  • CBER Health Achievement Award ERVEBO Review Team, 2020
  • CBER Group Recognition
    – Abbott Alinity’s Review Team, 2020
Education

B.S., Chemistry, University of California San Diego
Ph.D., Chemistry, University of California Santa Barbara
Post-Doctoral, Yale University

Practice Areas
Industries
FDA Regulatory Categories