Attorneys: Medical Device Companies Should Review DOJ Rule
Medical device companies with ties to China should prioritize compliance with DOJ’s new Data Security Program, attorneys at Hogan Lovells said Tuesday (see 2504140047).
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The rule could have a potential impact on companies’ manufacturing relationships, call centers, post-market surveillance and clinical trials involving data-sharing with Chinese entities, they said.
They recommended auditing manufacturing relationships, verifying that vendors aren’t covered under the rule, renegotiating vendor contracts, exploring alternative locations for call centers and training employees on the rule’s impact.