FDA 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes
标准简介
30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes[附网盘链接]是于之前发布的FDA标准，适用于U.S。标准截图
![30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes[附网盘链接]](/img/20210914103546r4cx6.jpg)
标准文档说明
标准文档类型为30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Contains Nonbinding Recommendations 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction Section 515(d)(6)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) provides that PMA supplements are required for any change to a device subject to an approved application that affects safety or effectiveness, unless such change is a modification in a manufacturing 1
procedure or method of manufacturing. The Act states that changes in manufacturing procedures or method of manufacturing that affect safety or effectiveness require a 30-day notice. Where FDA finds such notice inadequate, FDA will inform the applicant that a 135-day 2
PMA supplement or 75-day HDE supplement must be submitted. An HDE holder must submit supplements in accordance with PMA requirements under 21 CFR 814.39, except that requests 3
for a new indication for use of a HUD must comply with 21 CFR 814.110. However, the 4
timeframe for reviewing HDE supplements is 75 days. Thus, changes that would require a 135-
day supplement for a PMA would require a 75-day supplements for an HDE. The purpose of this 1
21 U.S.C. 360e(d)(6)(A) 2
21 CFR 814.39(f), 814.108 3
21 CFR 814.108 4
21 CFR 814.108 and 814.114.
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