Having spent more than a decade at the US Food and Drug Administration (FDA) in senior reviewer and regulatory policy roles, Atiq Chowdhury's practice focuses on advising FDA-regulated companies on a variety of regulatory, enforcement, compliance, and strategic matters. He routinely counsels pharmaceutical, medical device, and food companies, including start-ups to large manufacturers, on state licensing regulatory matters, fraud and abuse, and the development and regulation of medical devices, prescription and over-the-counter drugs, food, and dietary supplement products. Mr. Chowdhury assists clients, particularly in the diagnostics and medical technology fields, in becoming compliant with the Federal Food, Drug, and Cosmetic Act and the Clinical Laboratory Improvement Amendments. He also advises clients on the regulations of medical device software and mobile medical applications (MMA).

While at FDA, Mr. Chowdhury most recently was a Digital Health Policy Analyst in the Center for Devices and Radiological Health, and prior to this, served as a Lead Scientific Reviewer and Acting Regulatory Advisor. In these roles, he, among things, reviewed premarket notifications, premarket applications, investigational device exemptions, company q-sub requests, company promotional and compliance issues, and contributed to guidance documents and special projects. He also served as a Commissions Corps Officer with the US Public Health Service (PHS) for nearly a decade.

Credentials

Education
  • JD, The George Washington University Law School, 2018
  • MS, Systems Engineering, The George Washington University, 2009
  • BS, Biomedical Engineering, The George Washington University, 2007
Admissions
  • District of Columbia
Government & Military Service
  • Digital Health Policy Analyst, Center for Devices and Radiological Health, US Food and Drug Administration
  • Acting Regulatory Advisor, Center for Devices and Radiological Health, US Food and Drug Administration
  • Lead Scientific Reviewer, Center for Devices and Radiological Health, US Food and Drug Administration
  • Lieutenant Commander (LCDR), US Public Health Service Commissioned Corps
Overview

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