FDA Regulatory Due Diligence in Mergers and Acquisitions for Medical Device Companies
Whether your company is acquiring other device companies, or itself may be acquired, it is critical to understand the process and best practices for FDA regulatory due diligence. The presenters have counseled companies on numerous transactions involving medical devices, including conducting FDA regulatory due diligence for firms contemplating making an acquisition, as well as preparing acquisition targets for the types of diligence inquiries they may receive and how to respond. We will cover:
- Best practices and avoiding pitfalls when conducting FDA regulatory due diligence
- How to craft effective “reps and warranties”
- Integration and managing post-acquisition risks
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Due Diligence
Pamela F. Forrest
Covington & Burling LLP
Pamela Forrest has over 20 years of experience in advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, import/export issues, and clinical trial requirements.
Scott D. Danzis
Covington & Burling LLP
Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.
1 Hour Video | Jennifer Geettert and Lisa Schmitz Mazur, McDermott Will & Emery
1 Hour Video | Pamela F. Forrest and Scott D. Danzis, Covington & Burling LLP