Appendix 4. General Premarket Submission Documentation Elements and Scaling with Risk

본 지침에서 식별된 각 문서 유형은 사이버보안 위험이 존재하는 모든 장치의 시판 전 제출문서로 권장됨

ENDevice cybersecurity design and documentation are expected to scale with the cybersecurity risk of that device.

KR장치의 사이버보안 설계 및 문서화는 해당 장치의 사이버보안 위험 수준에 따라 확장(scale)되어야 합니다.

ENWhile documentation breadth is expected to scale, each type of documentation identified throughout the guidance is recommended for all premarket submissions for devices with potential cybersecurity risks.

KR문서의 범위는 위험 수준에 따라 확장되는 것이 기대되지만, 본 지침에서 식별된 각 문서 유형은 사이버보안 위험이 존재하는 모든 장치의 시판 전 제출(premarket submission)에 대해 권장됩니다.

시판 전 제출문서의 문서 유형

Type of Premarket Submission Documentation	IDE Submission
Cybersecurity Risk Management Report	Could be helpful to submit, but not specifically recommended
- Threat Model (may include Architecture Views)	Could be helpful to submit, but not specifically recommended
- Cybersecurity Risk Assessment	Could be helpful to submit, but not specifically recommended
- SBOM	Recommended
- Vulnerability Assessment and Software Support	Could be helpful to submit, but not specifically recommended
- Unresolved Anomalies Assessment	Could be helpful to submit, but not specifically recommended
- Traceability	Could be helpful to submit, but not specifically recommended
Measures and Metrics	Could be helpful to submit, but not specifically recommended
Architecture Views	Recommended
- Requirements	Recommended
- Architecture Views	Recommended
Labeling	Recommended
Cybersecurity Management Plan	Could be helpful to submit, but not specifically recommended