Claire Davies provides strategic counsel to help clients navigate FDA regulatory and compliance challenges.

Claire has handled a wide range of issues involving medical devices, biological products, drugs and human cells, tissues and cellular and tissue-based products (HCT/Ps). Her experience spans the product lifecycle and includes the following areas:

  • Investigational new drug application (IND), investigational device exemption (IDE) and other federal research requirements
  • Pathways to market for novel medical devices and digital health products
  • Regulatory classification of HCT/Ps and donor eligibility requirements
  • Adverse event reporting
  • Postmarket manufacturing and product changes
  • Responses to FDA Form 483 Observations
  • Advertising and promotion

Prior to joining Polsinelli, Claire spent nearly a decade as an attorney in the FDA’s Office of the Chief Counsel. Her work at FDA often involved advising agency leadership on high-profile and significant matters, such as responses to emerging public health threats and user fee negotiations with industry. Claire also worked regularly with FDA policy and scientific staff to develop regulations and guidance, resolve disputes with product sponsors, respond to citizen petitions and address compliance concerns through warning letters or other actions.

Education

  • University of Minnesota Law School (J.D., magna cum laude, Order of the Coif, 2010)
    • University of Wisconsin-Madison (B.S., with distinction, 2006)

      Bar Admission

      • Colorado
      • District of Columbia

      Professional Affiliations

      • Food and Drug Law Institute
      • Colorado Bar Association
      • Denver Bar Association

      Recognition

      • FDA Outstanding Service Award
      • Named one of Washington, D.C.'s Super Lawyers "Rising Stars", 2014-2015
      Publications
      All Publications
      Medspas on Alert: The FDA Says You’re a Dispenser Too
      Key Takeaways Medspas and other entities operating in the aesthetic space that dispense or administer prescription drugs should assess whether they have obligations as dispensers under the DSCSA and ensure they have policies, procedures and controls in place to demonstrate compliance with applicable requirements. To avoid the deficiencies cited in the warning letter, dispensers should focus on strengthening supply chain controls, maintaining complete product records and ensuring operational readiness for FDA inspection. Dispensers that receive a Form FDA 483 documenting observations of potential violations after an FDA inspection should act immediately to develop a thorough response with supporting documentation. On April 1, 2026, the FDA issued a warning letter to Pure Indulgence Aesthetics (Pure Indulgence), a Texas-based medical spa. Notably, this is the first
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      Tiny Chains, Big Changes? What FDA’s Latest Actions Mean for Peptide Compounding
      Key Takeaways: FDA will convene the Pharmacy Compounding Advisory Committee (PCAC) on July 23-24, 2026, to discuss seven peptides for potential inclusion on the 503A bulks list. An additional five peptides will be considered at a PCAC meeting to be held before the end of Feb. 2027. FDA separately announced on April 15, 2026, that these same substances will be removed from 503A Category 2 after seven calendar days because the nominations were withdrawn, although the agency confirmed it was still planning to bring them to PCAC. That procedural removal should not be read as a go-ahead to compound these peptides. Under FDA's current policy, removal of a bulk drug substance from Category 2 does not, on its own, authorize use of that
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