Jessica Ringel

Jessica Ringel is a Partner in King & Spalding’s FDA & Life Sciences practice group.  She advises medical device, pharmaceutical, and HCT/P manufacturers and distributors on matters involving FDA regulation across the entire product lifecycle.  Jessica’s post-market practice focuses on safety and quality matters, assisting 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.  Jessica’s pre-market practice includes advising on regulatory strategy and marketing applications and related submissions, including pre-submissions, 510(k)s, de novos, and PMAs.  She also assists clients with FDA-related import matters, including responses to import detentions to obtain the release of products held by 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.