FDA公布2022财政年可能会发布的医疗器械指南清单

设备和辐射健康中心（CDRH）每年都会发布计划在财政年度发布的指南文件的两份清单，包括：

A-list：计划在财政年度优先发布的指南文件清单。

B- list：计划在财政年度内资源允许的情况下发布的指南文件清单。

Retrospective review list：CDRH还会发布以前发布的指南的年度回顾清单，供利益相关者审查，并反馈意见，以确定是否应修订或撤销这些指南。

A-list中计划优先发布的指南上可根据当前优先事项以及收到的关于这些清单的评论予以删除或修改。

此外，FDA和CDRH的优先事项随时可能发生变化（例如，新发现的安全问题）。如果所需资源不利于满足定量审查时间表和法定义务，则不要求公布任何一份清单上的所有指南。此外，也不排除发布不在任何一份清单上的指南文件。

下面，一起来看下计划在2022年发布，修改或撤销的指南文件都有哪些？

2022财政年计划优先发布的指南文件清单（即，A-list）如下：

6个最终指南 Final Guidance Topics

• Clinical Decision Support Software

• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act

• Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order

• Remanufacturing of Medical Devices

• Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices

• Electronic Submission Template for Premarket Notification (510(k)) Submissions

大家可以留意到，网络安全指南没有放在2022年优先发布的最终指南里，而是放到了2022年优先发布的报告指南中，而且指南文件名称改了，改为

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions，看来对质量体系的要求会更严了。

10个草稿指南 Draft Guidance Topics

• Computer Software Assurance for Production and Quality System Software

• Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program

• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

• Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)

• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers 

• Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care

• Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act

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

2022财政年计划在资源允许的情况下发布的指南文件清单（即，B- list）如下：

2个最终指南 Final Guidance Topics

• Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices 

• Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations

5个草稿指南 Draft Guidance Topics

• Questions & Answers Regarding Certificates for Devices Not Exported from the United States (CDNE)

• Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions

• Content of Human Factors Information in Medical Device Marketing Submissions

• Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions 

• Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy, and Considerations

还包括如下回顾性审查指南：

Retrospective Review List of Guidances for 1982, 1992, 2002, and 2012

1982 Final Guidances

None

1992 Final Guidances

Review Criteria for Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19

2002 Final Guidances

Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry

General Principles of Software Validation: Guidance for Industry and FDA Staff

Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry

Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers

Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)

2012 Final Guidances

Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff

The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff

CDRH希望大家对以上三份清单中的指南文件发表意见。特别是，CDRH正在征求A-list和B-list中的指南文件的相对优先级，以及FDA提出的考虑纳入这些指南的政策或信息的意见。CDRH还欢迎就新的或不同的指南文件提出建议，并说明为什么需要关于所提主题的指南。

对于回顾性审查清单中的指南，CDRH正在寻求关于应修订或撤销哪些最终指南的建议，以帮助对现有最终指南进行回顾性审查。如果建议撤销或要求修改现有指南文件，CDRH要求评论人也补充关于为什么应修订或撤销指南文件以及如何修订（如适用）的信息。

如何递交意见？

1. 递交书面意见到Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 

书面意见中应识别docket number FDA-2012-N-1021 for "Notice to Public of Website Location of CDRH Fiscal Year 2022 Proposed Guidance Development."

2. 递交电子意见到 www.regulations.gov 这个网址。