Jessica A. Ritsick

FDA Legislation & Implementation

• Led the Center for Devices and Radiological Health’s (CDRH) drafting and negotiating of legislation amending the Federal Food, Drug, and Cosmetic Act (FDCA), including medical device shortages (FDCA § 506J) and medical device cybersecurity (FDCA § 524B).
• Facilitated CDRH’s implementation of medical device shortages authority during COVID-19 pandemic, including drafting multiple immediately-in-effect guidance documents and creating the medical device shortages list.
• Assisted with CDER’s implementation of the Drug Supply Chain Security Act (DSCSA), including drafting regulations and guidance documents and facilitating collaborations with state and other federal government agencies.

FDA Compliance & Enforcement

• Worked with multidisciplinary teams to craft warning and untitled letters and engage with industry stakeholders in matters of drug current good manufacturing practice (CGMP) compliance.
• Collaborated with the FDA’s Office of the Chief Counsel and the Department of Justice on the drafting and oversight of consent decrees of permanent injunction for violations of the FDCA related to CGMPs.
• Assisted in the drafting and oversight of FDCA § 522 orders for postmarket surveillance studies for high-risk medical device issues.

FDA Guidance & Policy Development

• Representative on various cross-center and cross-agency working groups, including Health of Women, Collaborative Communities, and opioids.
• Counseled multidisciplinary working groups to draft guidance and policy documents on a variety of topics, including DSCSA implementation, drug contract manufacturing arrangements, FDA drug and device inspections, medical device shortages, medical device cybersecurity, medical device servicing and remanufacturing, and 3D printing of medical devices.

Jessica Ritsick counsels clients that design, manufacture, sell, and distribute drugs, biologics, medical devices, food, and other FDA-regulated products. Jess draws on her experience working in the FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Human Foods Program (HFP), and her collaborations across the agency and federal government, to help advise on FDA policies and guidance and advise on compliance issues related to current good manufacturing practice (CGMP) violations, medical device shortages and cybersecurity, and the Drug Supply Chain Security Act (DSCSA).

Before joining Alston & Bird, Jess most recently served as regulatory counsel in the HFP’s Office of Policy, Regulations, and Information. Jess previously served as senior regulatory counsel in CDRH’s Office of Policy, where she advised on a variety of complex and high-profile regulatory and compliance matters, including serving on the COVID-19 pandemic response team, where she drafted and evaluated emergency use authorizations. Jess also served as regulatory counsel in CDER’s Office of Compliance in the Office of Manufacturing Quality and the Office of Drug Security, Integrity, and Response. Before joining the FDA, Jess was in private practice and also served as a law clerk to the senior judges at the District of Columbia Court of Appeals.

Bar Admissions

• District of Columbia
• New York

Education

• American University (J.D., 2011)
• St. Joseph’s University (B.A., 2007)

Memberships