Title:
[FDA Talk #1] : FDA’s Clinical Decision Support Software Guidance and Its Implications for the Industry
FDA’s regulation of digital health products is continuously evolving to ensure safe and effective products for patients,healthcare professionals, and caregivers, while fostering an environment that encourages innovation for the industry. FDA recently released final guidance for Clinical Decision Support software, which significantly narrowed the scope of the digital health products that are excluded (or exempted) from the “medical device” definition. Software product manufacturers are attempting to understand what this means and to adjust to this change in the regulatory environment. Sung Park and James Segroves will provide an overview of FDA’s current regulatory framework, and discuss what the companies should be thinking about in this constantly changing and evolving environment.
Date:
15 December 2022
8pm - 9pm (US EST)
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16 December 2022
10am - 11am (KST)
Webinar Link:
Passcode: 1234
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*Speakers;
Sung Park
Sung provides enforcement, regulatory, and transactional counsel to FDA-regulated companies in developing,distributing, and marketing FDA-regulated products and in particular, digital health products and solutions. Sung is experienced in designing regulatory routes for novel and complex medical device, drug, and digital health products that ensure that such products can reach the market quickly while minimizing the regulatory risk and burdens that the manufacturers and distributors are subject to.
Sung has experience reviewing product promotional materials; assisting with recalls and market withdrawals when needed; and working with FDA district offices and headquarters to minimize potential regulatory risk and to ensure that clients can successfully launch and market their products in the United States. Sung possesses nuanced understanding of the regulatory environment for digital health products, and has counseled companies in cutting edge issues, such as recalls and clinical trials for digital health products. Sung navigated companies through the complicated and challenging regulatory requirements that are applicable to digital health products.
Sung also conducts due diligence and represents the clients from an FDA regulatory perspective during merger and acquisitions, IPO, and other transactions. Sung conducted due diligence and identified material issues for clients, andalso reviewed and revised the transaction agreements to protect his clients’ interests. Sung is bilingual in English and Korean, and understands the unique challenges that companies face when marketing products in the U.S.
James F. Segroves
James represents members of the health and life sciences industries, trade associations, and other clients in important,precedent-setting cases at the trial and appellate levels of court systems throughout the United States, as well as matters before administrative and arbitral tribunals. These cases range from significant False Claims Act matters based on complicated regulatory theories, appeals from adverse judgments in cases presenting legal questions of first impression,reimbursement disputes involving hundreds of millions of dollars, substantive and procedural challenges of agency regulations, and matters before the Supreme Court of the United States with nationwide consequences.
James also advises clients with respect to legislative proposals pending before Congress on topics such as Medicare,Medicaid, the False Claims Act, and arbitration. In addition, he has significant experience advising clients regarding matters under consideration in the federal rulemaking process. For example, James has drafted regulatory commentsthat, on multiple occasions, have served as the basis for successful legal challenges of regulations promulgated by federal agencies.
Lastly, James has significant experience advising clients regarding critical issues arising during the COVID-19 pandemic.For example, he has advised numerous clients regarding the $178 billion grant program for eligible health care providers first established by the CARES Act, and has helped clients navigate other legislative and regulatory responses to the pandemic.