Cybersecurity in FDA 510(k) Submissions (Computers - Information Technologies)

Item ID 2882675 in Category: Computers - Information Technologies

Cybersecurity in FDA 510(k) Submissions


FDA cybersecurity entry, eligibility requirements, filing formats, and entry procedure, and provides helpful advice regarding an effective submission. The Cybersecurity in FDA 510(k), a premarket filing provided by the FDA, is an essential phase in demonstrating a brand-new healthcare product’s significant equivalency to a lawfully commercialised reference technology. The toolkit enables the compilation of extensive documentation on technical subjects, risk evaluation, and verification, guaranteeing FDA certification.

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Last Update : Feb 20, 2025 6:53 AM
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Item  Owner  : Qualysec
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