今天，FDA設備和放射衛生中心(CDRH)公布了其計劃在本財年(2023財年)發布的指南文件清單。

 

此外，CDRH承諾審查之前發布的最終指南文件，更新或撤回不再代表FDA當前監管問題想法的指南文件。

 

CDRH承諾，在資源允許的情況下，在評議期結束后3年內，對80%的指南文件草案定稿、撤回、重新開放評議期，或重新發布指南文件修訂草案。對其余20%的指南文件草案，在評議期結束后5年內完成。

 

CDRH公布了三個清單:

 

• A-list：FDA擬在2023財年公布的指南文件；

 

• B-list：FDA擬在2023財年資源許可的情況下發布的指南文件；以及

 

• Retrospective review list：將接受集中的回顧性審查的2013年、2003年、1993年和1983年發布的最終指南文件。

 

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

 

FDA CDRH 2023財年將發布以下7個最終指南

 

Final Guidance Topics

 

• Remanufacturing of Medical Devices 醫療器械再制造

 

• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency 新型冠狀病毒肺炎突發公共衛生事件期間的屬于執法政策范圍內的醫療器械過渡計劃

 

• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency 新型冠狀病毒肺炎突發公共衛生事件期間被授予緊急使用授權(EUAs)的醫療器械過渡計劃

 

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions醫療器械的網絡安全:上市前遞交的質量體系考慮和內容

 

• Content of Premarket Submissions for Device Software Functions 器械軟件功能上市前遞交內容

 

• Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program 促進醫療器械改進:FDA活動和自愿改進計劃的參與

 

• Breakthrough Devices Program (revised) 突破性器械項目(修訂)

 

FDA CDRH 2023財年將發布以下4個 草稿指南

 

Draft Guidance Topics

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

為制造商提供的自愿故障總結報告(VMSR)醫療設備報告(MDR)

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

針對阿片類藥物使用障礙的醫療器械上市前遞交的臨床考慮

 

• Select Updates for Guidance for the Breakthrough Devices Program

突破性器械項目指南的選擇性更新

 

• Electronic Submission Template for De Novo Request Submissions

De Novo請求遞交的電子遞交模板

 

 FDA CDRH在2023財年資源允許的情況下會發布的指南文件

 

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 過氧化氫隱形眼鏡護理產品-患者標簽建議

Draft Guidance Topics

• Chemical Analysis for Biocompatibility Assessment of Medical Devices 醫療器械生物相容性評價之化學分析

• Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 關于人工智能/機器學習(AI/ML)設備軟件功能變更控制計劃的上市遞交建議

• 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)

醫療器械臨床研究中性別數據和性別特定的評價(修訂“醫療器械臨床研究中性別數據評價”)

 

• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program 合格評定認可計劃(ASCA)試點項目

• 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 合格評定認可計劃(ASCA)試點項目標準特定信息-醫療電氣設備、醫療電氣系統和實驗室醫療設備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 合格評定認可計劃(ASCA)試點項目標準特定信息-醫療器械生物相容性測試

 

 FDA CDRH在2023財年將對以下最終指南進行回顧性審查

 

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