Jodi Scott developed and honed her practical, real-world sensibility and business acumen during the time she spent as an in-house FDA counsel with the world's largest medical device manufacturer.
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, and developing systems to mitigate the risks associated with the unapproved use of approved products (AKA off-label uses).
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 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, and demonstrates the company's commitment to safety and its regulatory obligations.
In addition to the issues that arise in her compliance practice, Jodi helps companies in developing regulatory strategies and preparing product applications, including IDEs, 510(k)s, and PMAs. 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.
Areas of Focus
Best Life Science Lawyer - Colorado
The Corporate America M&A Awards
Life Sciences Star
LMG Life Sciences