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今天，F(xiàn)DA設(shè)備和放射衛(wèi)生中心(CDRH)公布了其計(jì)劃在本財(cái)年(2023財(cái)年)發(fā)布的指南文件清單。

 

此外，CDRH承諾審查之前發(fā)布的最終指南文件，更新或撤回不再代表FDA當(dāng)前監(jiān)管問題想法的指南文件。

 

CDRH承諾，在資源允許的情況下，在評(píng)議期結(jié)束后3年內(nèi)，對(duì)80%的指南文件草案定稿、撤回、重新開放評(píng)議期，或重新發(fā)布指南文件修訂草案。對(duì)其余20%的指南文件草案，在評(píng)議期結(jié)束后5年內(nèi)完成。

 

CDRH公布了三個(gè)清單:

 

• A-list：FDA擬在2023財(cái)年公布的指南文件；

 

• B-list：FDA擬在2023財(cái)年資源許可的情況下發(fā)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(fā)布的最終指南文件。

 

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

 

FDA CDRH 2023財(cái)年將發(fā)布以下7個(gè)最終指南

 

Final Guidance Topics

 

• Remanufacturing of Medical Devices 醫(yī)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(fā)公共衛(wèi)生事件期間的屬于執(zhí)法政策范圍內(nèi)的醫(yī)療器械過渡計(jì)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(fā)公共衛(wèi)生事件期間被授予緊急使用授權(quán)(EUAs)的醫(yī)療器械過渡計(jì)劃

 

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions醫(yī)療器械的網(wǎng)絡(luò)安全:上市前遞交的質(zhì)量體系考慮和內(nèi)容

 

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

 

• Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program 促進(jìn)醫(yī)療器械改進(jìn):FDA活動(dòng)和自愿改進(jìn)計(jì)劃的參與

 

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

 

FDA CDRH 2023財(cái)年將發(fā)布以下4個(gè) 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Draft Guidance Topics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(jié)報(bào)告(VMSR)醫(yī)療設(shè)備報(bào)告(MDR)

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

針對(duì)阿片類藥物使用障礙的醫(yī)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(xiàng)目指南的選擇性更新

 

• Electronic Submission Template for De Novo Request Submissions

De Novo請(qǐng)求遞交的電子遞交模板

 

 FDA CDRH在2023財(cái)年資源允許的情況下會(huì)發(fā)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(hù)理產(chǎn)品-患者標(biāo)簽建議

Draft Guidance Topics

• Chemical Analysis for Biocompatibility Assessment of Medical Devices 醫(yī)療器械生物相容性評(píng)價(jià)之化學(xué)分析

• Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 關(guān)于人工智能/機(jī)器學(xué)習(xí)(AI/ML)設(shè)備軟件功能變更控制計(jì)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(yī)療器械臨床研究中性別數(shù)據(jù)和性別特定的評(píng)價(jià)(修訂“醫(yī)療器械臨床研究中性別數(shù)據(jù)評(píng)價(jià)”)

 

• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program 合格評(píng)定認(rèn)可計(jì)劃(ASCA)試點(diǎn)項(xiàng)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(píng)定認(rèn)可計(jì)劃(ASCA)試點(diǎn)項(xiàng)目標(biāo)準(zhǔn)特定信息-醫(yī)療電氣設(shè)備、醫(yī)療電氣系統(tǒng)和實(shí)驗(yàn)室醫(yī)療設(shè)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(píng)定認(rèn)可計(jì)劃(ASCA)試點(diǎn)項(xiàng)目標(biāo)準(zhǔn)特定信息-醫(yī)療器械生物相容性測(cè)試

 

 FDA CDRH在2023財(cái)年將對(duì)以下最終指南進(jìn)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