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False Claims Act Risks for Cyber Device Manufacturers Arising under New Requirements Subject to FDA Enforcement Beginning October 1, 2023

Companies with products or services reimbursed by the government are being increasingly scrutinized for their cyber-security practices under the False Claims Act. There is an increased risk for companies misrepresenting their cyber-security systems and procedures in pre-market submissions for FDA approval. False claims can result in extensive liability. Hence, accurate reporting of cyber-security systems is crucial for companies to manage their risk.

Source: www.gibsondunn.com –

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