Regulatory requirements and enlightenment from U.S FDA on medical devices used in treating benign prostatic hyperplasia
10.3969/j.issn.1672-8270.2025.06.030
- VernacularTitle:美国食品药品监督管理局对治疗良性前列腺增生的医疗器械监管要求分析
- Author:
Jing LIU
1
;
Zijing ZHOU
;
Weilu CHENG
;
Yidan ZHANG
;
Yaohua LI
Author Information
1. 国家药品监督管理局医疗器械技术审评检查长三角分中心 上海 201210
- Publication Type:Journal Article
- Keywords:
Benign prostatic hyperplasia(BPH);
Food and Drug Administration(FDA);
Supervision and administration of medical device;
Clinical study
- From:
China Medical Equipment
2025;22(6):158-162
- CountryChina
- Language:Chinese
-
Abstract:
Benign prostatic hyperplasia(BPH)is the main reason of causing lower urinary tract symptoms(LUTS)in middle-aged and elderly men,and LUTS can disrupt patients'sleep patterns and interfere with their daily life.With the development of aging,BPH has produced a significant impact on public health,and caused serious social problems and economic burdens.There are various technical approaches for medical devices used in treating BPH,including laser,electrosurgery,focused ultrasound,microwave,stent,and liquid jet removal system,etc.This article summarized the pathogenesis,clinical manifestations,and general overview for guidelines of diagnosis and treatment for BPH.It also reviewed the guiding principle of Food and Drug Administration(FDA)for medical devices used in treating BPH,and focused on analyzing the main contents of non-clinical study,animal study(including animal model,test method,observation time points and evaluation indicators)and clinical study(including selection for control groups,inclusion and exclusion criteria,study endpoint and study duration),so as to provide some enlightenments for the verification,validation and technical evaluation for such products.
