[Image courtesy of Adobe Stock/Tada Images

[图片由Adobe Stock/Tada Images提供]

The AP recently

美联社最近

reported

报告

that the Trump administration’s latest federal cuts have a significant effect on medical device regulation at the FDA.

特朗普政府的最新联邦预算削减对FDA的医疗器械监管产生了重大影响。

According to the report, the administration fired recently hired FDA employees reviewing, among other things, medical devices. Probationary employees in the FDA received notice of job elimination on Saturday evening, AP says. The news outlet cited three FDA staffers speaking on the condition of anonymity..

根据报告，管理局解雇了最近雇用的FDA员工，这些员工负责审查包括医疗设备在内的多项事务。美联社称，FDA的试用期员工在周六晚上收到了裁员通知。该新闻机构引用了三位要求匿名的FDA工作人员的说法。

AP said the total number of positions eliminated remain unclear. However, the report said cuts seem to center around employees in the agency’s centers for food, medical devices and tobacco products. This follows reports that officials expected the U.S. Dept. of Health and Human Services (HHS) to fire 5,200 probationary employees after the .

美联社表示，目前尚不清楚总共将裁减多少个职位。不过，报告称裁员似乎集中在该机构的食品、医疗器械和烟草产品中心的员工。此前有报道称，官员们预计美国卫生与公众服务部 (HHS) 将在之后解雇 5,200 名试用期员工。

confirmation of Robert F. Kennedy Jr. as HHS secretary last week

上周确认罗伯特·F·肯尼迪 Jr. 为卫生与公众服务部部长

.

。

According to the report, anonymous AP sources said they expected nearly 1,300 CDC employees to get laid off. As of early Sunday afternoon, the AP said about 700 people had received notices.

根据该报道，匿名的美联社消息人士称，他们预计CDC将有近1300名员工被解雇。截至周日早些时候，美联社称约有700人收到了通知。

(

(

Read about on the Trump administration’s actions and their potential impact on medtech HERE.

请在此处阅读有关特朗普政府的行动及其对医疗技术潜在影响的文章。

)

)

AdvaMed statement on latest cuts

关于最新削减的AdvaMed声明

An AdvaMed spokesperson shared the following statement by President and CEO Scott Whitaker with

以下是总裁兼首席执行官斯科特·惠特克分享的声明，由AdvaMed发言人提供：

MassDevice

MassDevice

via email:

通过电子邮件：

“We understand the ultimate goal of ensuring a more efficient and accountable federal government across the board. It is critically important, however, that the process of getting the latest and most promising U.S. medical technologies into the hands of our doctors and patients isn’t put at risk. A strong and effective FDA is an essential element of that process.

“我们理解确保整个联邦政府更加高效和负责任的最终目标。然而，至关重要的是，将最新和最有前途的美国医疗技术交到我们的医生和患者手中的过程不会受到威胁。一个强大而有效的FDA是这一过程的重要组成部分。

Patients’ lives, as well as our nation’s global leadership in medtech innovation, manufacturing, and jobs are potentially at stake. We are looking closely at this latest action, and will have further comment when we have a better sense of its potential impact.”.

患者的生命以及我国在全球医疗技术创新、制造和就业方面的领导地位可能岌岌可危。我们正在密切关注这一最新行动，并将在更好地了解其潜在影响后进一步发表评论。

FDA firings have an interesting relation to Musk’s Neuralink

FDA的解雇与马斯克的Neuralink有着有趣的关系

Reuters

路透社

reports that the FDA cuts extended to some agency employees reviewing Elon Musk’s Neuralink brain-computer interface (BCI) company.

报道称，FDA 的裁员还涉及到了一些负责审查埃隆·马斯克的 Neuralink 脑机接口 (BCI) 公司的机构员工。

The report said the firings included around 20 people in the FDA’s office of Neurological and Physical Medicine Devices. Several of those employees worked on Neuralink and other BCI devices, the report said, citing two sources with knowledge of the matter.

报道称，被解雇的人员包括美国食品药品监督管理局（FDA）神经和物理医学设备办公室的大约20人。报告援引两位知情人士的话称，其中几名员工从事Neuralink和其他脑机接口（BCI）设备相关工作。

Reuters

路透社

said both sources did not believe the Trump administration — and Musk as head of the Dept. of Government Efficiency (DOGE) — specifically targeted them due to their work on Neuralink’s regulatory submissions. The report, however, quoted former FDA official, Victor Krauthamer, expressing concern over the impact the cuts could have.

两位消息人士都表示，他们并不认为特朗普政府——以及作为政府效率部（DOGE）负责人的马斯克——是由于他们在Neuralink的监管文件工作而专门针对他们。然而，报告引用了前FDA官员维克多·克拉瑟默的话，表达了对这些削减可能带来的影响的担忧。

Krauthamer spent more than three decades at the FDA and spent time as acting director of the office that reviews human trial requests for BCIs..

克劳瑟在FDA工作了三十多年，并曾担任过审查BCI人体试验请求的办公室的代理主任。

“It’s intimidating to the FDA professionals who are overseeing Neuralink’s trial,” said Krauthamer. “We should be worried about the whole trial, and the protection of the people in the trial.”

“这令监督 Neuralink 试验的 FDA 专业人士感到害怕，”克劳萨默说。“我们应该担心整个试验，以及试验中的人们的保护。”

Affected FDA employees take to social media

受影响的FDA员工在社交媒体上发声

Here are some LinkedIn posts from current and former FDA employees detailing the impact of the latest cuts:

以下是现任和前任FDA员工在LinkedIn上发布的帖子，详细说明了最新裁员的影响：

Nathan Weidenhamer (biomedical engineer at FDA)

内森·魏登哈默（FDA的生物医学工程师）

: “Unfortunately, I was impacted by HHS’s recent decision to terminate probationary employees at the FDA. I am proud of the important work I accomplished with my colleagues in support of the FDA’s public health mission. I fear that these cuts will further exacerbate the challenges faced by the Agency to complete thorough regulatory review in a timely fashion.

：“不幸的是，我受到了美国卫生与公众服务部（HHS）最近决定解雇FDA试用期员工的影响。我为与同事们一起完成的、支持FDA公共卫生使命的重要工作感到自豪。我担心这些裁员将进一步加剧该机构在及时完成全面监管审查方面面临的挑战。

My colleagues in industry should be alarmed by these recent events and the potential impact to their development timelines.”.

我的行业同事应该对这些近期事件及其对他们的开发时间表的潜在影响感到警惕。”

Ramin Bighamian (biomedical engineer at FDA)

拉明·比格米安（FDA生物医学工程师）

: “I usually don’t talk about myself or my professional life on social media, but I feel it’s important to share the real impact of the recent federal layoffs on young professionals. Yesterday, I was terminated via a template letter—despite consistently receiving outstanding performance evaluations throughout my federal service.

：“我通常不会在社交媒体上谈论我自己或我的职业生涯，但我认为分享最近联邦政府裁员对年轻专业人士的真实影响是很重要的。昨天，我收到了一份模板式的解雇信——尽管我在联邦政府任职期间一直获得优异的绩效评价。

… After completing a full year of leadership training to prepare for a leadership role last year, I am now being terminated with just three months left in my probation—despite nearly six years of service.”.

… 在去年完成了一整年的领导力培训，为担任领导角色做准备后，尽管我已有近六年的工作经验，但现在距离试用期结束仅剩三个月，我却被解雇了。”

Julie Sullivan (FDA/CDRH division director — Radiological Imaging and Radiation Therapy Devices)

朱莉·沙利文（FDA/CDRH 分部主任——放射成像和放射治疗设备）

: “My office in CDRH was not spared from the purge that happened this weekend. We lost some really excellent people in the radiological health space who are now looking for work. Members of our teams have expertise in AI/ML, x-ray imaging (e.g., CT, mammography), radiation therapy- including carbon ion therapy, and software.

：“本周末的大清洗中，我在CDRH的办公室也未能幸免。我们失去了一些在放射健康领域非常出色的人才，他们现在正在寻找工作。我们的团队成员在人工智能/机器学习、X射线成像（例如CT、乳腺摄影）、放射治疗（包括碳离子治疗）以及软件方面具有专业知识。”

They’re adaptable, innovative, and hardworking.”.

他们适应性强、富有创新精神且勤奋努力。