Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC – Webinar Recording/Transcript
With the recent passing of the Food and Drug Omnibus Reform Act (FDORA) and other guidance and policy updates in medical device development, knowing and understanding all the new rules is crucial. And the FDA isn’t the only agency you have to worry about: the Department of Justice (DOJ) and the Federal Trade Commission (FTC) also play a part in enforcing new medical device rules.
This presentation, led by former FDA/DOJ officials, covers all the bases, giving you the information you need to avoid trouble from any of the three agencies.
Anne Walsh, director of Hyman, Phelps & McNamara, is a 25-year veteran of the pharmaceutical and medical device industries and has served as associate chief counsel with the FDA’s Office of Chief Counsel. She explains everything you need to know about FDA inspections, warning letters and recalls, as well as how to defend against DOJ prosecutions.
John Claud, counsel at Hyman, Phelps & McNamara, is a 15-year veteran of the DOJ. He has prosecuted and supervised complex criminal and civil trial litigation and investigations under the Food, Drug and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act and federal data privacy laws.
You will come away with a greater understanding of FDORA’s implications, as well as recently finalized guidance on delaying, denying, limiting or refusing an inspection, and the DOJ’s revised Corporate Enforcement Policy, which altered the way the agency reviews corporate criminal prosecution decisions.
- A comprehensive understanding of how FDA, DOJ and FTC coordinate their priorities and resources for enforcement actions of medical devices
- A review of recent FTC enforcement cases, with a focus on the perils of promoting claims that aren’t supported by science
- An explanation of the FTC’s health products compliance guidance and other rules
- Key updates from the FDA’s guidances on medical device-related cybersecurity
- Tips for navigating DOJ’s new Corporate Enforcement Policy
If you want to employ effective strategies to bridge gaps within your organization — while more effectively calculating risk and your ability to manage those risks — don’t miss the chance to gain insights from thought leaders and former employees of the FDA, DOJ and FTC.
Meet Your Presenters
Anne Walsh, director at Hyman, Phelps & McNamara, has more than 25 years of experience working with the pharmaceutical and medical device industries and regularly counsels clients facing FDA administrative actions, such as inspections, warning letters and recalls. Walsh conducts internal investigations to achieve compliance and position her clients to defend against DOJ prosecutions. She has investigated and negotiated dozens of matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Federal Trade Commission Act and exclusion authority of the HHS Office of Inspector General. Prior to joining Hyman, Phelps & McNamara, Walsh served as associate chief counsel with the FDA’s Office of Chief Counsel.
John Claud, counsel at Hyman, Phelps & McNamara, has more than 15 years of experience working with the DOJ. He has prosecuted and supervised complex criminal and civil trial litigation and investigations under the Food, Drug and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act and federal data privacy laws. He counsels FDA-regulated entities on litigation, enforcement and compliance matters, including FDA inspections, Form 483s, warning and untitled letters, consent decrees, internal investigations and data privacy concerns.
Who Will Benefit
- Medical device manufactures and executives
- Software developers
- Research institutions, researchers and statisticians
- Contract research organizations
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April 20, 2023