target audience: TECH SUPPLIER  Publication date: Jun 2023 - Document type: Market Note - Doc  Document number: # US50759823

New Era in Medical Devices Cybersecurity: Implications of the FDA's Latest Guidance Document for the Industry


  • Nino Giguashvili Loading
  • Silvia Piai Loading


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This IDC Market Note provides an overview of and insights into the FDA's final guidance document entitled "Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act," published on March 29, 2023.

"The new cybersecurity standards for medical device acceptance necessitate a paradigm shift in security management strategies for medical device manufacturers seeking to enter the U.S. market. Adopting integrated security-by-design approaches to managing security and building ecosystem-wide trust is imperative in this new era of medical devices cybersecurity." — Research Manager Nino Giguashvili, IDC Health Insights


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