人工智能设备软件功能：生命周期管理和营销提交建议_中英文
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Contains Nonbinding Recommendations
Draft – Not for Implementation
Artificial Intelligence-Enabled Device 1
Software Functions: Lifecycle 2
Management and Marketing 3
Submission Recommendations 4
5
Draft Guidance for Industry and 6
Food and Drug Administration Staff 7
8
DRAFT GUIDANCE 9
10
This draft guidance document is being distributed for comment purposes 11
only. 12
13
Document issued on January 7, 2025. 14
15
You should submit comments and suggestions regarding this draft document within 90 days of 16
publication in the Federal Register of the notice announcing the availability of the draft 17
guidance. Submit electronic comments to https://www.regulations.gov. Submit written 18
comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, 19
Room 1061, (HFA-305), Rockville, MD 20852-1740. Identify all comments with the docket 20
number listed in the notice of availability that publishes in the Federal Register. 21
22
For questions about this document regarding CDRH-regulated devices, contact the Digital Health 23
Center of Excellence at digitalhealth@fda.hhs.gov. For questions about this document regarding 24
CBER-regulated devices, contact the Office of Communication, Outreach, and Development 25
(OCOD) at 1-800-835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov. For questions 26
about this document regarding CDER-regulated products, contact druginfo@fda.hhs.gov. For 27
questions about this document regarding combination products, contact the Office of 28
Combination Products at combination@fda.gov. 29
30
U.S. Department of Health and Human Services 31
Food and Drug Administration 32
Center for Devices and Radiological Health 33
Center for Biologics Evaluation and Research 34
Center for Drug Evaluation and Research 35
Office of Combination Products in the Office of the Commissioner 36
包含无约束力的建议草案——不适用于实施
1人工智能设备软件功能：生命周期
2
管理与营销
3
提交建议
4
5
6行业和FDA工作人员的草案指南
7
8
指南草案
9
10
11 本指南草案仅供征求意见。
12
13
文件发布日期：2025年1月7日。
14
15
16
17 https://www.regulations.gov
18
19
20
您应在本指南草案公告于
《联邦公报》
发布之日起90日内提交意见和建议。电
子版意见请发送至 ，纸质版意见请寄至：美国食品药
品监督管理局档案管理处，地址：马里兰州罗克维尔市费舍斯巷5630号1061室
（邮编20852-1740），电话：（HFA -305）。所有意见请务必标注公告中公布的
《联邦公报》
档案编号。
21
22
23 digitalhealth@fda.hhs.gov
24
25
ocod@fda.hhs.
gov
26
druginfo@fda.hhs.gov
27
28
combination@fda.gov
如需咨询本文件中涉及 CDRH 监管器械的相关问题，请联系 数字
健康卓越中心。如需咨询本文件中涉及CBER监管器械的相关问题，请联系沟通、外联与发
展办公室（OCOD），电话1-800-835-4709或240-402-8010，或发送邮件至
。如需咨询本文件中涉及 CDER 监管产品的问题，请联系 。如需
咨询本文件中涉及组合产品的问题，请联系组合产品办公室，邮箱 。
29
30
31 美国卫生与公众服务部食品和药物管理局
32
器械与放射卫生中心
33
34 生物制品评价中心、药品评价与研究中心
35
专员办公室的组合产品办公室
36
Contains Nonbinding Recommendations
Draft – Not for Implementation
Preface 37
38
Additional Copies 39
40
CDRH 41
Additional copies are available from the Internet. You may also send an email request to 42
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 43
number GUI00007028 and complete title of the guidance in the request. 44
45
CBER 46
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 47
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 48
Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-49
8010, by email, ocod@fda.hhs.gov, or from the Internet at 50
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-51
biologics/biologics-guidances. 52
53
CDER 54
Additional copies are available from the Center for Drug Evaluation and Research (CDER), 55
Office of Communication, Division of Drug Information, 10001 New Hampshire Ave., 56
Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-0002, or by calling 855-543-3784 or 57
301796-3400, or by email, druginfo@fda.hhs.gov, or from the Internet at 58
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs. 59
60
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