今天，FDA设备和放射卫生中心(CDRH)公布了其计划在本财年(2023财年)发布的指南文件清单。

 

此外，CDRH承诺审查之前发布的最终指南文件，更新或撤回不再代表FDA当前监管问题想法的指南文件。

 

CDRH承诺，在资源允许的情况下，在评议期结束后3年内，对80%的指南文件草案定稿、撤回、重新开放评议期，或重新发布指南文件修订草案。对其余20%的指南文件草案，在评议期结束后5年内完成。

 

CDRH公布了三个清单:

 

• A-list：FDA拟在2023财年公布的指南文件；

 

• B-list：FDA拟在2023财年资源许可的情况下发布的指南文件；以及

 

• Retrospective review list：将接受集中的回顾性审查的2013年、2003年、1993年和1983年发布的最终指南文件。

 

A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2023

 

FDA CDRH 2023财年将发布以下7个最终指南

 

Final Guidance Topics

 

• Remanufacturing of Medical Devices 医疗器械再制造

 

• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency 新型冠状病毒肺炎突发公共卫生事件期间的属于执法政策范围内的医疗器械过渡计划

 

• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency 新型冠状病毒肺炎突发公共卫生事件期间被授予紧急使用授权(EUAs)的医疗器械过渡计划

 

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions医疗器械的网络安全:上市前递交的质量体系考虑和内容

 

• Content of Premarket Submissions for Device Software Functions 器械软件功能上市前递交内容

 

• Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program 促进医疗器械改进:FDA活动和自愿改进计划的参与

 

• Breakthrough Devices Program (revised) 突破性器械项目(修订)

 

FDA CDRH 2023财年将发布以下4个 草稿指南

 

Draft Guidance Topics

• Voluntary Malfunction Summary Reporting (VMSR) Medical Device Reporting (MDR) for Manufacturers

为制造商提供的自愿故障总结报告(VMSR)医疗设备报告(MDR)

• Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder

针对阿片类药物使用障碍的医疗器械上市前递交的临床考虑

 

• Select Updates for Guidance for the Breakthrough Devices Program

突破性器械项目指南的选择性更新

 

• Electronic Submission Template for De Novo Request Submissions

De Novo请求递交的电子递交模板

 

 FDA CDRH在2023财年资源允许的情况下会发布的指南文件

 

B-List: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2023

Final Guidance Topics

• Peroxide-Based Contact Lens Care Products – Patient Labeling Recommendations 过氧化氢隐形眼镜护理产品-患者标签建议

Draft Guidance Topics

• Chemical Analysis for Biocompatibility Assessment of Medical Devices 医疗器械生物相容性评价之化学分析

• Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 关于人工智能/机器学习(AI/ML)设备软件功能变更控制计划的上市递交建议

• Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision of Evaluation of Sex-Specific Data in Medical Device Clinical Studies)

医疗器械临床研究中性别数据和性别特定的评价(修订“医疗器械临床研究中性别数据评价”)

 

• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program 合格评定认可计划(ASCA)试点项目

• Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program 合格评定认可计划(ASCA)试点项目标准特定信息-医疗电气设备、医疗电气系统和实验室医疗设备的基本安全和基本性能

• Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program 合格评定认可计划(ASCA)试点项目标准特定信息-医疗器械生物相容性测试

 

 FDA CDRH在2023财年将对以下最终指南进行回顾性审查

 

Retrospective Review List of Guidances for 1983, 1993, 2003, and 2013

 

1983 Final Guidances

 

None

 

1993 Final Guidances

 

• Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology 

 

• Guidance for the Content of Premarket Notifications for Ureteral Stents 

 

• Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities [also see Addendum to:  Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities 9/95]

 

• Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers 

 

• Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles 

 

• Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes 

 

• Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson 

 

• Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) 

 

• Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes 

 

• Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities 

 

• Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators

 

• Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers

 

2003 Final Guidances

 

• Quality System Information for Certain Premarket Application Reviews 

 

• User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide 

 

• Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff 

 

• Coronary and Peripheral Arterial Diagnostic Catheters - Guidance for Industry and FDA Staff 

 

• Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions 

 

• Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA Staff

 

Premarket Approval Application Modular Review: Guidance for Industry and FDA Staff

 

• Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff

 

2013 Final Guidances

 

• CPG Sec. 390.225 Early Defects or Noncompliance - 21 CFR 1004.6

 

• Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff  

 

• Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff  

 

• Investigational Device Exemption (IDE) Guidance for Retinal Prostheses  

 

• Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff  

 

• Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff  

 

• Assay Migration Studies for In Vitro Diagnostic Devices  

 

• Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff 

 

• Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff

 

• Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff

 

• Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff