Holly N. Brevig Senior Regulatory Device and Biologics Expert 202-737-6109

Overview

Dr. Brevig started her 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.

She 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 (OCBQ).  There, she worked on manufacturing reviews for BLA supplements and EUAs.  She also conducted onsite Pre-Approval Inspections and site visits and reviewed records in advance and in lieu of an inspection.  Dr. Brevig also detailed with CBER’s Division of Case Management in OCBQ, reviewing 483s, Warning Letters, It Has Come to Our Attention Letters, Recalls, BPDRs, and Import Alerts.

Prior to the FDA, Dr. Brevig was a research analyst for the Center for Naval Analyses where she evaluated implementation of healthcare related programs and policies, and provided recommendations on funding science and technology programs for the Navy and Marine Corps.

Dr. Brevig earned a Ph.D. in Pharmacology from the University of Michigan, Ann Arbor.

Education & Admissions

Education

B.S., Biology, University of California, Irvine

Ph.D., Pharmacology, University of Michigan, Ann Arbor

Experience

  • Participated in multiple FDA inspections of manufacturing facilities devices and biologics (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 devices to ensure the safety of the patients in the study.
  • Reviewed product submissions, including, 510(k)s, PMAs, BLAs, EUAs, 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, BPDRs, and Recalls.
  • Experienced in the regulation of RUO, FUO, and LDT Products.
Education

B.S., Biology, University of California, Irvine

Ph.D., Pharmacology, University of Michigan, Ann Arbor

Practice Areas
Industries