About the Course
Introduction
This CLE webinar will examine FDA for-cause inspections as they relate to medical device manufacturers. The panel will discuss what actions trigger these inspections, how to prepare for the inspections, 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.
Description
FDA for-cause inspections are triggered when the agency has reason to believe that a facility has quality problems, to follow up on consumer complaints or adverse event reports, or to evaluate corrective actions made to address prior violations. These inspections differ from routine surveillance in that they are more targeted and in-depth than routine inspections and often unannounced.
A for-cause inspection may include comprehensive on-site inspections of the company's relevant systems, methods and procedures, and interviews with key employees. The inspections may also extend into the company's operations beyond the areas of initial concern.
For medical device manufacturers, these inspections may determine whether a product remains on the market or becomes the subject of regulatory action. Therefore, it is imperative that healthcare counsel understand how to prepare clients for possible for-cause inspections and how to guide them through the process should one of these inspections unexpectedly occur.
Listen as our expert panel examines FDA for-cause inspections focused on medical device manufacturers. The panel will discuss pre-inspection preparation 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 a for-cause inspection.
Presented By
Ms. 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, she brings unmatched insight and a pragmatic approach to solving high-stakes FDA issues. Widely regarded as a fixer in the medical device industry, Ms. Scott helps companies respond to and recover from FDA inspections, Form 483 observations, warning letters, and enforcement actions. She advises on FDA regulatory strategy, QMSR, medical device reporting, and recall management, aligning regulatory obligations with business goals. As a certified ISO 13485 auditor, she prepares companies for FDA, ISO, and MDSAP audits, and supports post-market compliance and state licensing requirements. As co-leader of the firm’s AI & Digital Health Working Group, Ms. Scott counsels on AI-enabled medical technologies, software as a medical device (SaMD), machine learning diagnostics, wearable health devices and other connected health technologies. Her practice spans the full product lifecycle, including regulatory due diligence for M&A, commercialization planning, and risk mitigation strategies.
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Date + Time
- event
Wednesday, February 18, 2026
- schedule
1:00 p.m. ET./10:00 a.m. PT
I. Introduction
A. FDA inspections generally
B. FDA inspections and enforcement activity under the current administration
II. FDA for-cause inspections
A. Affected parties
B. Inspection triggers
C. Navigating the inspection process
D. Penalties
III. Best practices for mitigating risk of for-cause inspections
A. Documentation
B. Internal processes
1. Compliance monitoring and audits
2. Corrective action
3. Employee training
4. Other
IV. Practitioner takeaways
The panel will review these and other important considerations:
- How do FDA for-cause inspections differ from routine inspections?
- What actions may trigger for-cause inspections?
- What should medical device manufacturers expect during an FDA for-cause inspection?
- What are best practices for helping clients prepare for these inspections? For navigating the inspection process? For mitigating the risk of for-cause inspections?
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