Unverified50% confidenceFactExact time
FDA issued updated medical device cybersecurity guidance in February 2026, covering cybersecurity design and premarket documentation requirements.
1
Sources
50%
Confidence
Medium-term (~90 days)
Relevance
10/12/2026
First Seen
Valid until: 1/10/2027
Sources
Related Entities
Related Claims
Unverified美国FDA已于2023年发布专项指南,认可合成医疗数据在特定条件下的监管有效性78% similarUnverifiedFDA在2021年为BCI设备发布了专门的指导草案70% similarUnverifiedFDA在2021年发布的《基于AI/ML的软件即医疗器械行动计划》中特别强调了算法透明度和实际性能监控的重要性70% similarUnverifiedThe US FDA published the "Artificial Intelligence/Machine Learning-Based Software as a Medical Device Action Plan" in 2021, introducing the concept of a Predetermined Change Control Plan.68% similarUnverified美国FDA在2021年发布《人工智能/机器学习医疗器械软件行动计划》,要求通过510(k)或PMA流程;欧盟MDR(2017/745法规)于2021年正式生效;中国NMPA于2021年发布《人工智能医疗器械注册审查指导原则》68% similar
Cite This Claim
Stable URI
https://kongchang.com/claim/1003990API
curl https://kongchang.com/api/v1/knowledge/claims/1003990MCP
get_claim(id=1003990)