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Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.
Ms. Kuhn frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions. She also has significant experience counseling medical device companies on postmarket compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, and recalls. She advises clients on responding to and resolving enforcement actions, such as FDA inspections and Warning Letters as well as Department of Justice investigations.
Ms. Kuhn advises clients on, and performs regulatory due diligence for, corporate transactions, including acquisitions, public offerings, co-development agreements, and clinical trial agreements.
Ms. Kuhn also regularly assists industry associations and medical device and pharmaceutical companies in commenting on FDA guidance documents and rulemaking as well as drafting and analyzing federal legislation.
Ms. Kuhn is a frequent contributor to Covington’s Digital Health and InsideMedicalDevices blogs.
- Advise multinational software company on FDA regulatory status of digital health products.
- Assist early-stage companies and multinational device manufacturers in preparing Pre-Submissions to FDA and obtaining FDA concurrence on regulatory pathway and clinical development programs.
- Outside counsel to PhRMA on FDA regulatory aspects of 21st Century Cures Act.
- Represent of major pharmaceutical companies in government investigations.
- Represent of a leading biotechnology firm in FDA proceedings relating to withdrawal of approval for a product.
- Develop citizen petitions for innovative companies regarding bioequivalence and other testing standards for generic drugs and related labeling requirements.
Pro Bono
- Submitted amicus brief on behalf of medical professional and public health organizations supporting the availability of aid in dying in litigation in the New Mexico Supreme Court and the Court of Appeals for the State of New York.
- Assisted reproductive rights non-profit analyze impact of bills creating the Women’s Health Protection Act on state laws.
- Incorporation of a tenants association and representation of the association under the D.C. Tenant Opportunity to Purchase Act.
- Favorable settlement for a non-profit mental health services agency in response to a race discrimination claim by a terminated employee filed with the District of Columbia Office of Human Rights.
Memberships and Affiliations
- New York State Bar Association
Previous Experience
- United States Attorney’s Office for the Southern District of New York, Civil Division, Intern (2010)
- New York County District Attorney’s Office, Paralegal (2005-2006)
October 8, 2019, Covington Digital Health
On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ...
September 24, 2019, Covington Digital Health
Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. “Ideation” is the part of that process and involves the rapid identification and creation of ideas for digital health solutions, which are then prototyped and tested. Covington has created a Top 10 Questions for Ideation of ...
2019, American Bar Association
Our cross-disciplinary Internet of Things initiative contributed to the ABA's first book on IoT, The Internet of Things: Legal Issues, Policy, & Practical Strategies. Laura Kim and Jennifer Johnson authored the chapter “U.S. Regulatory Framework for IoT,” with contributions from Sarah Wilson (product safety); Wade Ackerman, Elizabeth Guo, Christopher Hanson, ...
December 4, 2018, Covington Digital Health
As previewed by Commissioner Gottlieb several months ago (see our earlier post here), FDA published a notice in the Federal Register on November 20, 2018, to propose a new framework for “prescription drug-use-related software.” The Agency defines this digital health category widely as software disseminated by a prescription drug sponsor for use with the ...
May 7, 2018, Covington Digital Health
On April 26, Commissioner Gottlieb addressed the agency’s progress on FDA’s Digital Health Innovation Action Plan and announced several additional steps the agency is taking to advance the potential benefits of digital health. Here is a recap of the key updates: (1) Launch of New FDA Program to Apply Digital Health to Drugs As our...… Continue Reading
February 13, 2018, Covington Digital Health
On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals. Here are some key takeaways from that webinar: Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company...… Continue ...
December 21, 2017, Covington Digital Health
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...
December 20, 2017, Covington Alert
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...
December 19, 2017, Covington Digital Health
On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of Covington, covered ...
November 21, 2017, Covington Alert
In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory framework” for regenerative medicine products. On November 16, 2017, FDA issued four guidance documents outlining certain aspects of that framework. This alert summarizes each of the guidance documents and highlights ...
November 2017, Journal of Medical Device Regulation
September 20, 2017, Covington Alert
On August 18, 2017, President Trump signed H.R. 2430, the FDA Reauthorization Act of 2017, which became Public Law No. 115-52 (“FDARA”). Principally, FDARA reauthorizes the Food and Drug Administration (“FDA” or “the agency”) user fee programs, including the Medical Device User Fee Amendments, the Prescription Drug User Fee Amendments, the Biosimilars User Fee ...
August 3, 2017, Covington Digital Health
On Friday, July 28, FDA announced a new Software Pre-certification (Pre-Cert) Pilot Program in a Federal Register notice. The Pre-Cert program is one of three main action items discussed in the agency’s recently-released Digital Health Innovation Action Plan. CDRH also held a webinar on August 1 to provide an overview of the program and answer...… Continue ...
August 3, 2017, Covington Digital Health
On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month. The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and ...
January 30, 2017
WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in its agreement to acquire a portfolio of intrathecal spasticity and pain management drugs from Mallinckrodt LLC. The purchase price was $171 million, plus an earn-out of up to an additional $32 million. This is the third acquisition that ...
December 6, 2016, Covington Alert
On November 8, 2016, the U.S. Food and Drug Administration (FDA) published a final guidance titled Medical Device Reporting for Manufacturers (“Final Guidance”). The guidance explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. On November 30, ...
Postmarking Issues
November 3, 2016, FDLI Introduction to Medical Device Law and Regulation Course
Short Course: Digital Health Technologies for Combination Products and Beyond: Development and Regulation
October 24-26, 2016, DIA Combination Products Conference 2016: Current, Evolving, and Future Pathways
Wade Ackerman and Christina Kuhn taught the short course “Digital Health Technologies for Combination Products and Beyond: Development and Regulation” at DIA’s Combination Products 2016 conference. When it comes to the regulatory path to market for digital health technologies that touch upon drug products, much attention has been paid to FDA’s device center, but ...
Dealing with Adverse Events/Product Problems
June 13-14, 2016, FDLI/CDRH In-House Training: Introduction to Medical Device Law and Regulation Workshop
April 7, 2016, Covington Digital Health
On April 5, the Federal Trade Commission (FTC), in conjunction with the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), released a new web-based interactive tool to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and...… ...
Postmarket Issues And Strategies
March 31, 2016, FDLI Hot Topics in Medical Device Law Conference
Covington Represents Underwriters in Senseonics' IPO
March 24, 2016
NEW YORK - Covington advised the underwriters in the $45 million initial public offering of common stock of Senseonics Holdings, Inc. The offering closed on March 23, 2016. Shares of Senseonics trade on the NYSE MKT under the ticker “SENS.” Senseonics develops continuous glucose monitoring systems for patients with diabetes. Its Eversense product consists of ...
Premarket Approvals (PMAs)
September 16, 2015, FDLI/CDRH In-House Training: Introduction to Medical Device Law and Regulation Workshop
August 21, 2014, Covington E-Alert
August 2012, Journal of Medical Device Regulation
FDA Issues Proposed Rule to Establish a Unique Device Identification System for Medical Devices
July 16, 2012, Covington Advisory
FDA Issues Draft Guidance on Evaluating Substantial Equivalence in 510(k) Premarket Notifications
February 7, 2012, Covington E-Alert
June 22, 2011, Covington E-Alert