Jennifer assists clients in navigating a wide variety of FDA regulatory compliance issues, including:
- Registering and listing with FDA.
- Determining whether a particular product is subject to FDA regulation and if so, FDA requirements applicable to the particular product.
- Guiding clients through the 510(k) clearance process.
- Advising on advertising and labeling.
- Drafting/reviewing policies and procedures.
- Responding to FDA compliance and enforcement activities.
- Reviewing the overall state of FDA compliance through the due diligence or audit process.