I don’t want to keep two separate lists for everything, so if it’s not a cyber device, just ignore that stuff ok test

List of Cybersecurity Input Docs

Overarching

• ISO/IEC 27001
• NIST Cybersecurity Framework

FDA

• Content of Premarket Submissions and QMS considerations
  • Current - Docket Number FDA-2021-D-1158 / Published Sept 2023
  • Proposed Draft - Docket Number FDA-2021-D-1158 / Published March 2024
• Postmarket Guidance
  • (Docket Number FDA-2015-D-5105) / Published Dec 2016
• Networked Medical Devices containing OTS Software
  • (Docket Number FDA-2020-D-0957 / Published Jan 2005)

EU

• MDR 2017/745
• MDCG 2019-16
• NIS2 Directive 2022/2555
  • [[10142401451 RN NIS2 Cybersecurity Directive 2022-2555]]

Country-specific

• Germany
  • BSI (the German Federal Office for Information Security) is implementing NIS2 as the “NIS2UmsuCG”, expected to be in force in March 2025 with no transition period.
• UK: MHRA Guidance
• Switzerland: MedDO

Technical standards

• IEC 62304
• IEC 80001-1
• ISO 14971
• UL 2900-1

Human Resources / Access Control

• ISO/IEC 27002

• NIST SP 800-53

FDA

EU

** MDR**

• Risk management to address cybersecurity throughout device lifecycle. (Ref?)
• Devices must be designed/manufactured with state-of-the-art security measures. (What are those measures?)
• Postmarket surveillance to include monitoring and responding to cybersecurity vulnerabilities. (Reference cited)

AUS

Others