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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.
FDA, FTC and DOJ Enforcement of Medical Device Regulations will give you the confidence to make the right moves to keep your medical devices in compliance.
Former DOJ attorney John Claud clarifies the overlapping enforcement authority among these entities and explains the recent changes, including the FDA’s expanded authority under FDORA for medical device companies, that delay, deny, limit or refuse an inspection, and DOJ’s changes to the ways it evaluates corporate criminal prosecution decisions.
The report features examples of enforcement actions by FDA, FTC and DOJ and explains the potential for civil and criminal enforcement actions targeting issues such as data privacy, cybersecurity and corporate compliance management.
If you don’t have a handle on these changes, don’t stay in the dark. Get answers to your questions and stay compliant with FDA, FTC and DOJ Enforcement of Medical Device Regulations.
Management Report Takeaways:
- The implications of the FDA’s expanded authority to ban devices for one or more intended uses or off-label uses
- The overlapping enforcement authorities of the FDA and FTC
- New FDA guidance to mitigate the cybersecurity risks of connected devices
- Lessons from recent False Claims Act cases against devicemakers
- Factors DOJ considers when deciding to pursue a device company for wrongdoing
You can bridge the gaps within your organization, improve your ability to work with practitioners across all device-related fields, avoid enforcement actions and stay compliant. Let FDA, FTC and DOJ Enforcement of Medical Device Regulations show you the way.
About the Contributor
John Claud, counsel at the law firm Hyman, Phelps & McNamara, advises 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. A 15-year veteran of the DOJ, he most recently served as assistant director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.
Who Will Benefit
- Medical device executives
- Quality and regulatory professionals
- In-house counsel
- Regulatory personnel
- Software engineers
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Contributor:
John Claud
ISBN:
978-1-60430-214-1
Publication date:
June 2023
Page count:
183
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