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Jessica Ringel advises medical device, pharmaceutical, HCT/P, and cosmetics manufacturers and distributors on matters involving FDA regulation. Jessica’s post-market practice focuses on safety and quality matters, including responses to FDA inspections and enforcement actions, recall and adverse event matters, and advertising and promotion. Her pre-market practice includes advising on regulatory strategy and marketing applications. Jessica’s transactional practice involves conducting due diligence evaluations of life sciences targets for manufacturers, private equity firms, and investment banks.
Jessica’s device regulatory practice spans the entire FDA regulatory lifecycle. She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs. After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters. She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans. Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations. She further assists life sciences clients with the review and development of compliant marketing strategies and materials. She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA. Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA’s electronic product radiation control program. Further, Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA.
Jessica’s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company. She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance.
J.D., Georgetown University, magna cum laude
B.A., Cornell University, with distinction
District of Columbia
Maryland
September 21, 2023
LMG Life Sciences Recognizes King & Spalding With Multiple Rankings in its 2023 Guide
April 11, 2023
Eric Henry, Kyle Sampson, Jessica Ringel and Lisa Dwyer’s client alert is referenced in a profile on the FDA’s PCCP guidance
November 15, 2022
Jessica Ringel discusses the recently reauthorized Medical Device User Fee Amendments V and the creation of the Total Product Life Cycle Advisory Program
August 10, 2023
FTC Revamps the “Guides Concerning the Use of Endorsements and Testimonials in Advertising”
June 28, 2023
FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions
April 6, 2023
FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped?
September 21, 2023
LMG Life Sciences Recognizes King & Spalding With Multiple Rankings in its 2023 Guide
April 11, 2023
Eric Henry, Kyle Sampson, Jessica Ringel and Lisa Dwyer’s client alert is referenced in a profile on the FDA’s PCCP guidance
November 15, 2022
Jessica Ringel discusses the recently reauthorized Medical Device User Fee Amendments V and the creation of the Total Product Life Cycle Advisory Program
August 10, 2023
FTC Revamps the “Guides Concerning the Use of Endorsements and Testimonials in Advertising”
June 28, 2023
FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions
April 6, 2023
FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped?
September 21, 2023
LMG Life Sciences Recognizes King & Spalding With Multiple Rankings in its 2023 Guide
April 11, 2023
Eric Henry, Kyle Sampson, Jessica Ringel and Lisa Dwyer’s client alert is referenced in a profile on the FDA’s PCCP guidance
November 15, 2022
Jessica Ringel discusses the recently reauthorized Medical Device User Fee Amendments V and the creation of the Total Product Life Cycle Advisory Program
J.D., Georgetown University, magna cum laude
B.A., Cornell University, with distinction
District of Columbia
Maryland