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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.
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