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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 InsideMedicalDevices blog.
- 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)
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 ...
FDA Publishes Draft Guidance on Investigational IVDs Used in Therapeutic Product Clinical Trials
December 22, 2017, Inside Medical Devices
On December 18, 2017, FDA announced the availability of a new draft guidance, titled “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.” The draft guidance is intended to inform both product sponsors and IRBs regarding the application of the Investigational Device Exemption (IDE) regulation to investigational in vitro diagnostic ...
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 21, 2017, Inside Medical Devices
FDA has described its evolving approach to regulating digital health and decision support software in two new draft guidance documents: Clinical and Patient Decision Support Software and Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act. These draft guidances announce the agency’s initial interpretation of ...
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 22, 2017, Inside Medical Devices
Last month, President Trump signed the FDA Reauthorization Act of 2017 (FDARA). FDARA reauthorizes the Medical Device User Fee Amendments (MDUFA), allowing FDA to collect medical device user fees for fiscal years 2018 to 2022 after FDA’s current user fee authority ends on September 30, 2017. Notably, the reauthorized MDUFA adds a substantial new user...… ...
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, Inside Medical Devices
In two new posts on the Covington Digital Health blog we analyze the Digital Health Innovation Action Plan recently released by FDA and the agency’s new software pre-certification (Pre-Cert) pilot program. The Digital Health Innovation Action Plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning ...
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 ...
August 2, 2016, Inside Medical Devices
FDA recently published a draft guidance document titled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.” A companion diagnostic is an in vitro diagnostic device that provides “information that is essential for the safe and effective use of a corresponding therapeutic product.” The new draft guidance is ...
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, Inside Medical Devices
A new post on the Covington eHealth blog discusses the new web-based interactive tool released by the FTC to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and data security and privacy.… Continue Reading
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 ...
January 7, 2016, Inside Medical Devices
On December 28, 2015, CDRH posted two lists of guidance documents that the Center intends to publish in FY 2016: the “A-list” of draft and final guidance documents that FDA “fully intends to publish,” and the “B-list” of draft and final guidance documents that FDA intends to publish “as resources permit.” FDA agreed to publish...… Continue Reading
December 22, 2015, Inside Medical Devices
On December 18, President Obama signed into law the Consolidated Appropriations Act, 2016 (H.R. 2029), which includes a two-year moratorium on the medical device excise tax. The 2.3 percent tax on sales of medical devices (except certain devices sold at retail) was enacted as part of the Affordable Care Act in 2010 and applied to...… Continue Reading
December 2, 2015, Inside Medical Devices
On November 17, 2015, the House Energy & Commerce Subcommittee on Health held a hearing examining the regulation of laboratory developed tests (LDTs). CMS Deputy Administrator Patrick Conway and CDRH Director Jeffrey Shuren testified regarding the respective roles of CMS and FDA in the oversight of LDTs. The day before the hearing, FDA issued a...… Continue ...
November 12, 2015, Inside Medical Devices
Today we published a post on the Covington eHealth blog regarding the HHS Office of Inspector General’s (OIG) Work Plan for fiscal year 2016. The post describes OIG’s plan to review FDA’s oversight of medical devices networked to electronic medical records and hospital systems.… Continue Reading
November 12, 2015, Covington Digital Health
On November 2, 2015, the HHS Office of Inspector General (OIG) published its FY 2016 Work Plan, which summarizes new and ongoing activities that OIG plans to pursue with respect to HHS programs and operations during the fiscal year. The FY 2016 Work Plan includes a new review initiative to examine “whether FDA’s oversight of...… Continue Reading
Premarket Approvals (PMAs)
September 16, 2015, FDLI/CDRH In-House Training: Introduction to Medical Device Law and Regulation Workshop
July 9, 2015, Covington Digital Health
Bloomberg BNA reports (subscription required) that FDA will recognize a regulatory category called “complementary diagnostics” for tests that provide additional information about how a drug might be used, but that are distinct from “companion diagnostics,” which are essential for the safe and effective use of a drug. Elizabeth Mansfield, Deputy Director for ...
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