Drawing on experience at the FDA, I provide clients with a comprehensive knowledge and an in-house perspective on FDA issues that affect their business operations.*Counseled genetic test developer on preparation of its Special 510(k) for test modifications.*Advised a specialty cosmetics marketer on off-package ingredient labeling for e-commerce sales.*Prepared an overview of applicable CGMP requirements for Phase 1 investigational drug articles for a foreign cancer drug developer.*Provided counseling on transfer of device registration and listings in an asset sale transaction.*Advised digital health companies regarding FDA’s and FTC’s enforcement of general wellness devices.*Advised a medical device manufacturer regarding responding to an FDA enforcement letter regarding its adverting and promotion of its device.

CDRH - Office of In Vitro Diagnostics and Radiological Health

FDA Practice Group