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White House Releases National Cybersecurity Strategy Implementation Plan - Security

On July 13, 2023, the White House unveiled its National Cybersecurity Strategy Implementation Plan (NCSIP or implementation plan), following.

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FDA To Require Demonstration Of Cybersecurity Safeguards For Pre-Market Submissions Of Certain Medical Devices - Security

On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration ("FDA") issued a series of FAQs[1] and a guidance document[2] clarifying the agency's intended.

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The importance of networking in information security

The increasing sophistication of network attacks challenge organizations large and small

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FDA To Require Demonstration of Cybersecurity Safeguards for Pre-Market Submissions of Certain Medical Devices | Sheppard Mullin Richter & Hampton LLP

On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration (“FDA”) issued a series of FAQs and a guidance document clarifying the agency’s intended implementation of the.

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Cybersecurity Safeguards for Pre Market Medical Devices FDA

Guidance documents from FDA clarifying agency implementation of Consolidated Appropriations Act that amended Section 524B of the Food Drug and Cosmetics Act to require the demonstration of cybersecurity safeguards in pre market submissions for certain medical devices.

States pharmacopeiaUs food drug administrationUs food drug administration marNational formularyProduct development protocolDepartment of homeland securityDrug administrationConsolidated appropriations actCosmetics actSubmissions are subjectNew cybersecurityHumanitarian device exemptionNew requirements fitCurrent regulatoryMedical devicesQuality system considerations

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