Regulatory challenges in innovation and evaluation of extracorporeal membrane oxygenation: Database analysis and future perspectives

• Guohui Jiao,
• Yuji Wang,
• Yulong Guan,
• Xiaofan He,
• Jingjing Miao,
• Kun Wu,
• Jingyu Chen,
• Qingfeng Luo,
• Yuanyuan Ji

Affiliations

Guohui Jiao

1 Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China

Yuji Wang

1 Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China

Yulong Guan

2 Department of Extracorporeal Circulation, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China

Xiaofan He

3 Guangdong Medical Devices Quality Surveillance and Test Institute, NMPA Key Laboratory for Extracorporeal Circulation Devices, Guangzhou, Guangdong 510663, China

Jingjing Miao

1 Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China

Kun Wu

1 Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China

Jingyu Chen

4 Wuxi Lung Transplant Center, Wuxi People’s Hospital Affiliated to Nanjing Medical University, Wuxi, Jiangsu 214023, China

Qingfeng Luo

1 Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China

Yuanyuan Ji