David Filmore がリツイート
A change to @FDA_ORA is coming soon! The organization is realigning to better support the agency’s mission and so is our X account! Stop by tomorrow to say hello and to learn our new handle name!
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David Filmore
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David Filmore
@Filmoreorless
Really only On Here now for #Knicks and #NBA twitter
Brighton, NY 参加日 Mayıs 2013
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@GishConsulting @Market_Pathways Good point - the non-up classified class I's don't get much attention amid all the MDR angst. Happy to chat about this issue sometime if you're interested (for Market Pathways)
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@Market_Pathways That’s except for the lowest-risk devices; non-up classified Class I.
The regulatory intelligentsia seem to think they can all reach full compliance, without any extensions. Those products continue to disappear from the EU market and no one is talking about it.
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"Implementing the Medical Device Regulation (#MDR) has been a frantic game of catch-up for the past six years or so. That still remains the case in many ways. But the urgency dialed down several notches earlier this year..." #medicaldevices
Market Pathways | MedTech Regulatory & Policy@Market_Pathways
In this month’s spotlight from Pathways’ Document Depot: EU organizations, including the European Commission and TEAM-NB, rolled out resources and arguments engaging with the recently extended Medical Device #Regulation transition: bit.ly/3Rswi83 #medtech
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David Filmore がリツイート
#CMS unveiled its Transition Coverage for Emerging Technologies proposal last week—the agency’s second go-around at trying to streamline #Medicare coverage of innovative new devices. Here’s our initial analysis of the plan, with 10 key takeaways. ➡️ tinyurl.com/3y5bsk6c
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David Filmore がリツイート
The European Medicines Agency (@EMA_News) will launch a year-long pilot next month to give 10 makers of innovative devices the opportunity to get early feedback from EU expert panels on clinical trial planning to facilitate the MDR assessment process. #regulatory
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Interesting impact analysis from use of 510(k) predicates that underwent high risk (class I) recalls
Kushal Kadakia, MD@ktkadakia
@US_FDA @JAMA_current @CesarCaraballoC @jsross119 @hmkyale @JAMAInternalMed (9/15) Lastly, we matched recalled predicates to contemporaneously authorized recall-free controls, and compared recall rates among descendants. The risk of a Class I recall was increased *sixfold* for devices that used a recalled predicate.
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The only pushback to the EU Commission's plan during the Council briefing was from Malta, who preferred setting one new transition date - in 2028 - for all devices, rather than risk-based phases
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The Commission plans to introduce legislation to make the extension happen early next year, according to EU Health Commissioner Stella Kyriakides.
In the meantime, "bridging" measures for devices whose CE marks are expiring soon will be issued by the Commission in coming days
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During EU Council meeting just now: Health ministers unanimously spoke in support the European Commission's proposal to extend EU Medical Device Regulation transition: to 2027 for high-risk devices and 2028 for low-mid-risk devices.
#Medicaldevices
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Top @Medtronic execs recently met with FDA about AI-enabled products
Also noteworthy: they apparently traveled to meet onsite at FDA headquarters, which is not so common nowadays
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David Filmore がリツイート
What Do the US Midterms Mean for #Medtech?
@medicaldevices's Mark Leahey and @AdvaMedUpdate's Greg Crist offer their perspectives on this podcast with Market Pathways editors Stephen Levin (@StephenLevinMTS) and David Filmore (@MedtechDavid). ➡ bit.ly/3P03sJe
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David Filmore がリツイート
#Regulatory Doc of the Week: "Guiding Principles for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part III: Biological Compatibility/Toxicological Evaluation (Draft)"
View the document here (link in Simplified Chinese). ➡️cmde.org.cn/xwdt/zxyw/2022…
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David Filmore がリツイート
China’s National Medical Products Administration is consistently one of the most prolific #regulatory agencies in publishing guidance and other #medtech policy documents. NMPA issued 26 documents last month— mostly technical review guidelines—to the US FDA’s 14.
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The dude in this story who vomited in a trash can after being told he had to cut hundreds from his team is my people nytimes.com/2022/11/11/tec…
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Look out for our new Doc of the Week threads 👇
And subscribe to @Market_Pathways to access Document Depot - a continuously updated database of medtech regulatory, reimbursement, policy documents from US, Europe, Asia and elsewhere >
bit.ly/3nlJpY6
Market Pathways | MedTech Regulatory & Policy@Market_Pathways
#Regulatory Doc of the Week: “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions: Guidance for Industry and #FDA Staff” @US_FDA, October 26, 2022 Here are 3 reasons why this matters. 🧵⬇️
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CMS coverage office hasn't had a lot of staff turnover, according to CAG director Tamara Syrek Jensen. "I hope I'm not jinxing myself," she says. @MedTechCon #medtechcon
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CMS Tamara Syrek Jensen: On the day the (repealed) Medicare Coverage of Innovative Technology (MCIT) was set to take effect last year, "it was not going to work." CMS didn't have tools in place to implement it, she says at @MedTechCon panel this morning #medtechcon #Medicare
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David Filmore がリツイート
Join our Editor-in-Chief @DCassak at #MedTechCon presented by @AdvaMedUpdate, Monday, October 24 from 4:30 PM to 5:00 PM in the panel session, "Care of the Future: Smarter, Less Invasive, More Personalized." Learn more here. ➡️ themedtechconference.com/2022-agenda/
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David Filmore がリツイート
We’re ready and excited for #MedTechCon in beautiful Boston presented by @AdvaMedUpdate. Check us out at Booth 213 and come meet our team. 👋
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David Filmore がリツイート
In this month’s spotlight from Pathways’ Document Depot, Malaysia and the Philippines roll out policy docs that build on the decade-long project to harmonize device regulations in Southeast Asia. ➡️ bit.ly/3eMjsR9 #regulatory #medtech
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