Standards, Guidance & Notices
Showing 131–134 of 134
NIST
SP
SP
SP 800-39
Managing Information Security Risk: Organization, Mission, and Information System View
The purpose of Special Publication 800-39 is to provide guidance for an integrated, organization-wide program for managing information security risk to organizational operations (i.e., mission, functions, image, and reputation), organizational assets, individuals, other organizations, and the Nation resulting from the operation and use of federal information systems. Special Publication 800-39 provides a structured, yet flexible approach for managing information security risk that is intentionally broad-based, with the specific details of assessing, responding to, and monitoring risk on an ongoing basis provided by other supporting NIST security standards and guidelines. The guidance provided in this publication is not intended to replace or subsume other risk-related activities, programs, processes, or approaches that organizations have implemented or intend to implement addressing areas of risk management covered by other legislation, directives, policies, programmatic initiatives, o
Published: 2011-03-01
IEC
IEC/TR 80002-1:2009
Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
Provides guidance on the application of ISO 14971 to medical device software, addressing software-specific aspects of risk management.
Published: 2009-08-01
FDA
CDRH
CDRH
FDA-Cybersecurity-OTS-2005
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
Early FDA guidance (2005) on cybersecurity management of off-the-shelf (OTS) software incorporated into network-connected medical devices. It sets out the division of responsibilities between manufacturers and healthcare facilities and the approach to operating system patching, antivirus protection, and access control. Useful for understanding the regulatory history as a predecessor of the current final cybersecurity guidance (first issued in September 2023 and since revised, including the June 2025 version).
Published: 2005-01-14
FDA
CDRH
CDRH
FDA-SW-Validation-2002
General Principles of Software Validation — Final Guidance
FDA final guidance (Version 2.0) setting out the general principles applicable to the validation of medical device software and of software used in design and manufacturing. It systematically organizes the concepts of the software life cycle, verification, and validation. It continues to serve as a reference document after the adoption of IEC 62304 and is a foundational document for preparing premarket submissions.
Published: 2002-01-11
