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Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA

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Morrison Foerster lawyer Atiq Chowdhury will teach the session “Is My Digital Health Product a Medical Device Regulated by FDA?”...

Morrison Foerster lawyer Atiq Chowdhury will teach the session “Is My Digital Health Product a Medical Device Regulated by FDA?” during the Food & Drug Law Institute’s virtual course, “Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA” on February 25, 2025, from 11:05 a.m. to 12:05 p.m. PT. This virtual course will explore the essentials of FDA regulation of innovative medical device technologies, and how these categories of products are regulated as medical devices.For more information about the Food & Drug Law Institute’s virtual course “Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA,” and to participate in this event, please visit the <a href="https://www.fdli.org/2025/02/2025-fundamentals-of-digital-health-regulation-successfully-navigating-your-product-through-fda/" target="_blank">registration page</a>.<hr>

Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA

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Atiq Chowdhury is an associate in the FDA + Healthcare Regulatory and Compliance practice, where he advises FDA-regulated companies on a wide range of regulatory, enforcement, and compliance matters. He counsels pharmaceutical, medical device, and food companies on FDA regulatory requirements, fraud and abuse issues, states’ corporate practice of medicine and licensing matters. Atiq focuses on assisting clients in the diagnostics, software as a medical device, mobile medical applications, and medical technology fields in becoming compliant with the Federal Food, Drug, and Cosmetic Act and the Clinical Laboratory Improvement Amendments. Prior to joining Morrison Foerster, Atiq practiced at other leading international law firms. For more than a decade, he also worked in reviewer and policy roles at the U.S. Food and Drug Administration (FDA). In these roles, he reviewed Premarket Approval notifications and applications, Investigational Device Exemptions, Q-Submission requests, and promotional and compliance issues, and contributed to guidance documents and other agency policy priorities. He also served as a Commissioned Corps Officer in the U.S. Public Health Service (PHS) for nearly a decade. While at the FDA, Atiq was honored by the FDA Center for Devices and Radiological Health (CDRH) with the Special Recognition Award for MDUFA III Assessment and Implementation and the Excellence in Compliance and Enforcement Award. He also received Commendation and Citation medals from the PHS for his contributions to approving and clearing first-of-their-kind diagnostic and therapeutic devices.Atiq’s experience has included, for example:<ul><li>Assisting clients with interactions between FDA and other global health authorities related to drug and device submissions (e.g., Investigational New Drugs, New Drug Applications, Q-Submissions, 510k applications, Investigational Device Exemptions, De Novo submissions, and Premarket Approval applications).</li><li>Advising clients on FDA regulations and global regulatory strategies related to the development of drug, device, and combination product marketing applications which include software applications, companion diagnostics, diagnostic tests, biomarkers, and digital health tools.</li><li>Advising medical device and pharmaceutical facilities on preparation for FDA inspections or responding to FDA Form 483 observations, import alerts, and warning letters, as well as developing site remediation work plans.</li><li>Performing gap assessments for device and drug manufacturers across a range of quality systems, including complaint handling, corrective and preventive actions, good documentation practices, supplier management, and adverse event safety reporting.</li><li>Supporting internal investigations concerning alleged cGMP/QSR compliance violations at FDA-regulated manufacturing facilities based in the United States, Europe, and Asia.</li><li>Representing and advising large healthcare and life sciences companies, as well as small biotech and medtech companies, on acquisitions, mergers, joint ventures, and other arrangements.</li></ul>

Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA

25 Feb 2025 11:05 AM - 12:05 PM PST