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Christopher Hanson assists clients in tackling their most sophisticated and high-stakes regulatory issues involving medical devices, in vitro diagnostics, clinical laboratories, and radiation-emitting electronic products. For nearly a decade, he has aided clients in interactions with federal, state, and foreign regulatory agencies, including the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), the Federal Trade Commission (FTC), and the Substance Abuse and Mental Health Services Administration (SAMHSA). His broad range of clients include large multinational companies, venture capital firms, industry associations, and development-stage companies.

Mr. Hanson takes a hands-on approach in crafting creative and practical solutions for clients. His work includes drafting legislation as well as preparing public comments for agency rulemakings, guidance documents, advisory committees, and other public policy venues. He provides strategic advice and regulatory due diligence to support corporate transactions and securities filings. He also has experience advising in enforcement matters and conducting global internal investigations and audits of the firm’s life science clients in the United States, Asia, Australia, Europe, and Latin America.

  • Advised global healthcare company GSK on FDA and CLIA regulatory components of the company's $300 million equity investment and collaboration with 23andMe.
  • Co-drafted legislation signed into law in California and New Jersey concerning the regulation of state clinical laboratories.
  • Successfully petitioned FDA for removal of certain Class II medical devices from an import alert.
  • Assisted diagnostics manufacturer in preparing a 510(k) notification and receiving FDA premarket clearance for a Class II device.
  • Represented industry association in FDA meetings regarding medical device and radiation-emitting electronic product proposed rulemakings.
  • Drafted Congressional white paper and request for a hearing in response to FDA’s Notice of Opportunity for Hearing (NOOH), proposing to withdraw approval of certain new animal drug applications (NADAs).
  • Represented industry association before the Division of Clinical Laboratory Improvement & Quality (CMS) and prepared public comments concerning various CLIA proposed rulemakings.
  • Assisted medical device manufacturer in preparing response to FDA Warning Letter and drafting CDRH Pre-Submission (Pre-Sub) materials.
  • Represented industry association in submitting public comments to Congress concerning in vitro diagnostic (IVD) draft legislation.
  • Prepared responses to several FDA “It Has Come to Our Attention” (IHCTOA) letters and represented medical device manufacturers in FDA meetings.
  • Assisted medical device and pharmaceutical manufacturers in preparing initial and follow-up responses to FDA Form 483 Observations.
  • Advised global pharmaceutical company in interactions with California and New York state clinical laboratory regulators.
  • Drafted FDA regulatory expert report and presentation for Swedish arbitration concerning certain Class II medical devices.
  • Provided FDA regulatory diligence to client for $1.7 billion acquisition of a clinical-stage biopharmaceutical company.
  • Prepared public comments and drafted proposed regulations on behalf of client before the Texas Forensic Science Commission.
  • Wrote position papers concerning proposed legislation involving medical device and pharmaceutical regulation in foreign jurisdictions, including Canada and India.
  • Conducted large-scale, internal assessment of global pharmaceutical company’s manufacturing division.
  • Represented top global pharmaceutical company in internal review of procedures and policies concerning investigator-initiated trials (IITs).
  • Led internal review of procedures and policies concerning product labeling for cosmetics manufacturer.

Pro Bono

  • Represented Federally Qualified Health Center (FQHC) in drafting several rounds of FDA public comments and advisory committee public testimony concerning agency blood donation guidelines.
  • Represented federal inmate in seeking a Presidential clemency grant.
  • Successfully represented Latin American immigrant in U visa application.
  • Authored white paper on behalf of global pro bono law firm analyzing how parties become signatories to intrastate peace agreements.
  • Represented LGBT organization in litigation involving transgender military service members.
  • Assisted LGBT organization in preparation for potential election referendum on state transgender rights law.
  • Advised transgender individuals on legal name and gender change procedures in Maryland, Virginia, and Washington, DC.
  • Conducted 50-state survey of Medicaid and prescriptive authority law for health care non-profit.

Memberships and Affiliations

  • Harvard University, Divinity School Alumni/ae Council (Chairperson, 2016-2017) and Divinity School Bicentennial Host Committee (Co-Chair)
  • Yale College, Class of 2005 Reunion Chair and Association of Yale Alumni (AYA) Class Representative
  • Point Foundation, Wells Fargo Scholar and Mentorship Committee (former)

Previous Experience

  • United States Senate, Constituent Services (2008-2010)
  • Harvard University, Harvard Humanitarian Initiative Instructor (2008)
  • Yale University, Assistant Director of Undergraduate Admissions (2005-2007)