FDA For-Cause Inspections Targeting Medical Device Manufacturers: Navigating the Process, Mitigating Risks
April 13, 2026
10:00 AM – 11:00 AM
Examine FDA for-cause inspections and their impact on medical device manufacturers.
Presented by Hogan Lovells
FDA For-Cause Inspections Targeting Medical Device Manufacturers: Navigating the Process, Mitigating Risks
April 13, 2026
10:00 AM – 11:00 AM
FDA For-Cause Inspections Targeting Medical Device Manufacturers: Navigating the Process, Mitigating Risks
April 13, 2026
10:00 AM – 11:00 AM
Join Hogan Lovells as they examine how FDA for-cause inspections impact medtech manufacturers. The panel will discuss what actions trigger these inspections, how to prepare for them, and what to expect during the inspection process. The panel will also offer best practices for helping clients mitigate the risk of being the target of an FDA for-cause inspection.
What You’ll Cover
- What triggers FDA for-cause inspections
- How these inspections differ from routine reviews
- What to expect during the inspection process
- Best practices to reduce risk and strengthen compliance
Date: Monday, April 13, 2026
Time: 10:00 AM – 11:00 AM ET
Location: Online
Meet the Speakers
Jodi Scott, Partner, Co-Lead Global Medical Devices and Technology Practice, Hogan Lovells
Jodi K. Scott is a nationally recognized FDA regulatory attorney known for guiding medical device and digital health companies through complex compliance challenges and regulatory crises. With prior experience as in-house FDA counsel at Medtronic PLC, the world’s largest medical device manufacturer, Jodi brings unmatched insight and a pragmatic approach to solving high-stakes FDA issues.
Widely regarded as a fixer in the medical device industry, Jodi helps companies respond to and recover from FDA inspections, Form 483 observations, warning letters, and enforcement actions. Her calm, strategic leadership ensures clients maintain compliance while protecting business continuity and reputation.
Mike Heyl, Partner, Hogan Lovells
Mike Heyl helps medical device companies navigate myriad regulatory and business matters. He guides clients through U.S. Food and Drug Administration (FDA) regulations, requirements, and compliance issues. These issues include FDA’s Quality System Regulation (QSR); adverse event reporting; recall reporting requirements; FDA inspections and enforcement actions, such as Warning Letters; defense strategies; and corrective and remedial action plans.
He represents large multinational corporations facing FDA and criminal enforcement, and helps small startups develop and implement postmarket compliance programs. Because he understands FDA’s requirements for importing and exporting medical devices, Mike is frequently called on to negotiate the release of detained goods being imported to the United States.
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