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
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