（美国食品药品监督管理局）
2023年7月25日，美国FDA公布了以下新闻概览：
7月24日，针对其于2023年6月15日在《联邦公报》上就其计划进行的题为“包装食品上的包装正面标签的定量研究”的研究发布的一份为期30天的程序通知，美国FDA重新开放了公众意见征询期，新的征求意见截止日期为2023年7月26日（周三）23:59。
7月24日，美国FDA认可了以下灭菌标准和技术信息报告（TIR），有助于推进医疗器械灭菌工艺的创新。这些最新内容更新在“认可的共识标准”数据库（认可清单编号60）中，包括：
-新的灭菌标准和报告：
ISO 22441:2022
AAMI TIR104:2022
AAMI TIR17:2017/(R)2020
-认可标准的新版本
-对部分标准的认可范围做出的修改
-两份标准的过渡期延长
对ISO 22441:2022、AAMI TIR104:2022和AAMI TIR17:2017/(R)2020的完全认可，体现了美国FDA为推进医疗器械灭菌工艺的创新而做出的持续努力。据此，制造商可以采用低温汽化过氧化氢（LT-VHP）灭菌技术，器械上市申请人在上市前审查阶段提交申请时也会有更多的选择。
7月21日，美国FDA驳回了一份*愿请**书，该*愿请**书要求FDA重新考虑其于2022年5月19日发布的公民*愿请**书驳回决定。该公民*愿请**书请求禁止8种邻苯二甲酸盐的使用，并撤销5种邻苯二甲酸盐先前在食品中的许可用途，理由是存在所谓的安全问题。邻苯二甲酸盐通常被称为“邻苯二甲酸酯”，是一种用于塑料产品（最常见的是聚氯乙烯塑料，又称PVC或乙烯基塑料）的化学物质，可使材料柔软而不易碎。
7月21日，美国FDA批准了Cordis Palmaz Mullins XD肺动脉支架，用于接受肺动脉狭窄（PAS）治疗的儿科患者。肺动脉狭窄是一种严重的先天性心脏病。需通过一根插入患者血管的导管，将支架植入肺动脉。支架可解决肺动脉严重狭窄的问题，保持肺动脉通畅，减轻心脏右心室的压力负荷，同时改善肺部血流。这是首款批准用于治疗儿科患者肺动脉狭窄的器械，为患者提供了不同的治疗方案。美国FDA医疗器械与放射健康中心（CDRH）心血管器械办公室主任Bram Zuckerman指出：“此次批准基于来自登记系统数据的真实世界证据。真实世界证据可以帮助克服研究儿科患者用医疗器械时面对的一些困难，此次批准是使用真实世界证据推进儿科患者医疗护理的一个很好的范例。”
英文原文
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
On Monday, the FDA reopened the comment period for the 30-day procedural notice to conduct a study entitled “Quantitative Research on Front of Package Labeling on Packaged Foods” that appeared in the Federal Register on June 15, 2023. The new deadline for comments will be 11:59 PM on Wednesday, July 26, 2023.
On Monday, the FDA recognized the following sterilization standards and Technical Information Reports (TIRs) to help advance innovation in medical device sterilization processes. This latest update to the Recognized Consensus standards database is known as “List 60,” and includes:
new sterilization standards and reports:
ISO 22441:2022
AAMI TIR104:2022
AAMI TIR17:2017/(R)2020
New versions of recognized standards
Revisions to some standards’ extent of recognition
Extended transition periods for two standards
The complete recognition of ISO 22441:2022, AAMI TIR104:2022, and AAMI TIR17:2017/(R)2020 is part of our ongoing efforts to advance innovation in medical device sterilization processes. It supports manufacturers’ use of low temperature vaporized hydrogen peroxide and provides more options for device sponsors to consider for submission during the premarket review process.
On Friday, the FDA denied a petition requesting that the agency reconsider its denial of a citizen petition issued on May 19, 2022. The citizen petition requested a ban on the use of eight ortho-phthalates and revocation of the prior sanctioned uses for five ortho-phthalates in food based on alleged safety concerns. Ortho-phthalates, often referred to as “phthalates,” are chemicals used in plastic products (most commonly in the specific type of plastic named polyvinyl chloride, also known as PVC or vinyl) to make the material soft and less brittle.
On Friday, the FDA approved the Cordis Palmaz Mullins XD Pulmonary Stent for pediatric patients receiving treatment for pulmonary artery stenosis (PAS). PAS is a narrowing of a pulmonary artery, which is a serious form of congenital heart disease. The stent is placed in the pulmonary artery through a catheter inserted through the patient’s blood vessel. The stent addresses the critical narrowing of the pulmonary artery and keeps the pulmonary artery open, decreasing the pressure load on the right ventricle of the heart while improving blood flow to the lungs. This approval marks the first device of its kind approved to treat PAS in pediatric patients that offers an additional treatment option for patients. “This device approval is supported by real world evidence obtained from registry data,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “Real world evidence can help overcome some of the challenges presented when studying medical devices in pediatric populations. This approval is a great example of the use of real-world evidence to advance the care of pediatric patients.”
来源：FDA
整理翻译：奥咨达