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FDA公布2022財(cái)政年可能會(huì)發(fā)布的醫(yī)療器械指南清單

 

設(shè)備和輻射健康中心（CDRH）每年都會(huì)發(fā)布計(jì)劃在財(cái)政年度發(fā)布的指南文件的兩份清單，包括：

 

A-list：計(jì)劃在財(cái)政年度優(yōu)先發(fā)布的指南文件清單。

 

B- list：計(jì)劃在財(cái)政年度內(nèi)資源允許的情況下發(fā)布的指南文件清單。

 

Retrospective review list：CDRH還會(huì)發(fā)布以前發(fā)布的指南的年度回顧清單，供利益相關(guān)者審查，并反饋意見(jiàn)，以確定是否應(yīng)修訂或撤銷(xiāo)這些指南。

 

A-list中計(jì)劃優(yōu)先發(fā)布的指南上可根據(jù)當(dāng)前優(yōu)先事項(xiàng)以及收到的關(guān)于這些清單的評(píng)論予以刪除或修改。

此外，F(xiàn)DA和CDRH的優(yōu)先事項(xiàng)隨時(shí)可能發(fā)生變化（例如，新發(fā)現(xiàn)的安全問(wèn)題）。如果所需資源不利于滿(mǎn)足定量審查時(shí)間表和法定義務(wù)，則不要求公布任何一份清單上的所有指南。此外，也不排除發(fā)布不在任何一份清單上的指南文件。

 

下面，一起來(lái)看下計(jì)劃在2022年發(fā)布，修改或撤銷(xiāo)的指南文件都有哪些？

 

2022財(cái)政年計(jì)劃優(yōu)先發(fā)布的指南文件清單（即，A-list）如下：

6個(gè)最終指南 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，網(wǎng)絡(luò)安全指南沒(méi)有放在2022年優(yōu)先發(fā)布的最終指南里，而是放到了2022年優(yōu)先發(fā)布的報(bào)告指南中，而且指南文件名稱(chēng)改了，改為

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions，看來(lái)對(duì)質(zhì)量體系的要求會(huì)更嚴(yán)了。

10個(gè)草稿指南 Draft Guidance Topics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財(cái)政年計(jì)劃在資源允許的情況下發(fā)布的指南文件清單（即，B- list）如下：

2個(gè)最終指南 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個(gè)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

 

還包括如下回顧性審查指南：

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希望大家對(duì)以上三份清單中的指南文件發(fā)表意見(jiàn)。特別是，CDRH正在征求A-list和B-list中的指南文件的相對(duì)優(yōu)先級(jí)，以及FDA提出的考慮納入這些指南的政策或信息的意見(jiàn)。CDRH還歡迎就新的或不同的指南文件提出建議，并說(shuō)明為什么需要關(guān)于所提主題的指南。

 

對(duì)于回顧性審查清單中的指南，CDRH正在尋求關(guān)于應(yīng)修訂或撤銷(xiāo)哪些最終指南的建議，以幫助對(duì)現(xiàn)有最終指南進(jìn)行回顧性審查。如果建議撤銷(xiāo)或要求修改現(xiàn)有指南文件，CDRH要求評(píng)論人也補(bǔ)充關(guān)于為什么應(yīng)修訂或撤銷(xiāo)指南文件以及如何修訂（如適用）的信息。

 

如何遞交意見(jiàn)？

 

1. 遞交書(shū)面意見(jiàn)到Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 

 

書(shū)面意見(jiàn)中應(yīng)識(shí)別docket number FDA-2012-N-1021 for "Notice to Public of Website Location of CDRH Fiscal Year 2022 Proposed Guidance Development."

 

2. 遞交電子意見(jiàn)到 www.regulations.gov 這個(gè)網(wǎng)址。