Jodi Scott

Today, she uses that background to solve the challenges that confront her clients in areas that include MDRs, regulatory due diligence, importing and exporting medical devices, advertising and promotion, preparing for and managing FDA inspections, developing systems to mitigate the risks associated with the unapproved use of approved products (AKA off-label uses), developing digital health technology, and securing the necessary state medical device manufacturer and distributor licenses.

Jodi assists the medical device industry in navigating the complex requirements so as to maintain compliance with the U.S. Food and Drug Administration's (FDA) quality system (QSR) and other post-market regulatory rules. She spends much of her time developing and implementing strategies to manage FDA-initiated enforcement actions, such as FDA inspections that result in FDA Form 483s, untitled letters, Warning Letters, investigations, and consent degrees of permanent injunction. She has received ISO 13485 auditor certification and assists companies in preparing for managing and responding to ISO and MDSAP audits.

She also guides her clients through complex medical device recalls by helping them work through the difficult decisions of whether a recall is warranted and, if so, how to execute it in a way that best achieves a balance between patient and customer risk and the agency's interests, while also demonstrating the company's commitment to safety and its regulatory obligations.

She also applies her regulatory knowledge in assisting clients with regulatory due diligence related to mergers and acquisitions and funding, such as private equity deals, initial public offerings, and other financial transactions.

Jodi co-leads the firm’s cross-functional Digital Health Working Group and regularly assists clients in navigating the complexities of FDA regulation of digital health technologies with an eye to helping them meet their business objectives while being mindful of the potential for regulatory obligations.