The Consolidated Appropriations Act of 2023 (Omnibus) amended the Federal Food, Drug, and Cosmetic Act to require medical device manufacturers to address cybersecurity. As of March 29, 2023, they must provide cybersecurity details in premarket submissions. The Omnibus mandates plans for postmarket cybersecurity vulnerabilities, device cybersecurity demonstrations, and software bill of materials (SBOM) disclosures. Starting October 1, 2023, the FDA will reject submissions not meeting cybersecurity criteria, emphasizing proactive cybersecurity measures.
Data-loss prevention company Cyberhaven hit by breach, statement says, ET Telecom
Hackers have compromised an employee of data protection firm, Cyberhaven, to potentially steal sensitive information from the company’s users. The hackers have allegedly used the
