FDA premarket requirements / Vernessa T. Pollard and Anisa Mohanty -- FDA regulation of digital health care products / Jeffrey N. Gibbs and Allyson B. Mullen -- Data, clinical trials, and good clinical practices / Gerard Prud'homme, Kristen Zielinski Duggan, Megana Sankaran -- Intellectual property protections for medical devices / Ed Buthusiem, Jeffrey Klenk, and Eric Carlson -- Business arrangements and contractual agreements / David Hatch and Robert Miller -- Postmarket requirements / Paul Gadiock and Jamie Ravitz -- Compliance and enforcement / Paul Gadiock and Jamie Ravitz -- Import/exports / Allison Fulton -- Fraud and abuse laws / Charlene Cho and Jennifer Michael -- Coverage, coding, and reimbursement for medical devices / Beth Halpern, with Mahmud Brifkani, Boyd Jackson, Soraya Keskey, and Maria Malas -- AI--products liability / Terrence Dee.
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