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.