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Här bjuder MedTechbloggen på lite info från den kinesiska myndigheten SFDA.

• The State Food and Drug Administration (SFDA) released the second issue of 2010 National Medical Device Quality Announcement on July 8,2010 and publicized the quality sampling and testing results of some in vitro diagnostic reagents.
• On July 1, 2010, the State Food and Drug Administration (SFDA) issued the Second Summary of Announcements of Illegal Drug, Medical Device, and Health Food Advertisements in 2010.
  

För din info:

SFDA releases the second issue of 2010 National Medical Device Quality Announcement

The State Food and Drug Administration (SFDA) released the second issue of 2010 National Medical Device Quality Announcement on July 8,2010 and publicized the quality sampling and testing results of some in vitro diagnostic reagents.

En titt i NMAs utbildningsprogram för hösten avslöjar bla en spännande kurs för mjukvaruutvecklare inom det medicintekniska området, 14 - 15 sepember:

“The course details the software validation requirements that need to be addressed during design control [21CFR Part 820.30(g)] and [§7.3 of the EN ISO 13485] for software developments.
There will be sessions on software risk management, development life-cycle, architecture, design, software verification and validation.
Software validation of proprietary medical device products, subcontracted and off-the-shelf software will also be covered.
Incorporation of EN ISO 14971, Medical devices - Risk management - Application of risk management to medical devices and AAMI /TIR 32 Medical device software risk management into the software life-cycle processes will be shown. And references to the coming guideline IEC/TR 80002-1 “Medical device software - Guideline on the application of ISO 14971 to medical device software”
All current documentation of the FDA and EU software regulatory requirements will be included in the course binder.
The format will include lectures, discussions groups and case studies.”

Intresserad? Förhandsanmäl dig till info(at)nordicmedicaladvisor.se

Svenska företag påverkas när FDA effektiviserar. Pressrelease från FDA 26/4 2010:

“FDA Changes Process for Medical Device Advisory Committees
Goal is improved discussion and flow of information

The U.S. Food and Drug Administration today announced that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval, effective May 1, 2010.

The changes were prompted by an increasing number of medical device advisory panel meetings in recent years. In 2008, there were 10 panel meetings covering 14 major topics. In 2009, there were 17 meetings on 20 topics, and 2010 is on track to surpass those numbers, according to the FDA’s Center for Devices and Radiological Health (CDRH).

The increased activity has created challenges for CDRH and the way it operates panel meetings. In accord with current agency policy and guidance for advisory committees, the changes address staffing issues, voting procedures, and other items related to information presentation and flow of discussion.

“These changes are expected to empower the agency to make more effective decisions that are informed by more clear and focused discussion by panel experts,” said CDRH Director Jeffrey Shuren, M.D.

In the past, panel discussions have not always reflected a panel’s final vote on approvability. Now, instead of voting on the approvability of premarket approval applications, including conditions of approval, the panel will vote on the safety and effectiveness of a device and the device’s risk versus its benefit.

“By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes,” Shuren said. “The change also will allow panel members to address issues related to their area of expertise instead of regulatory issues that may be unfamiliar to them.”

In addition, panels will vote by ballot instead of by a show of hands. While the votes will be publicly tallied so that panel members can be identified by their vote, the ballot process allows each panel member to cast his or her vote without immediate influence by other votes.

There are many issues involved in the FDA’s review of a medical device. Historically, the FDA’s presentations to panels included comments on approvability. With the changes, the FDA’s presentations will continue to include reviews of the agency’s data analysis, but will no longer include comments on approvability.

Before the changes, the agency medical device reviewers presented a unified, consensus analysis of supporting data. Now, reviewers will present together with data and analysis, the range of scientific opinion in the group. This move will allow more in-depth discussion on safety and effectiveness and risk versus benefit of the device under consideration.”

Info från Kinesiska läkemedelsmyndigheten:

“On March 26, 2010, Shao Mingli, Commissioner of the State Food and Drug Administration, met with the visiting Dr. Heinz Zourek, Director-General of Directorate-General Enterprise and Industry of the European Commission, and his party. Both parties reviewed the favorable cooperation since the establishment of the Consultation and Cooperation Mechanism in October 2007, and exchanged views on Sino-European cooperation in the supervision of drugs, medical devices, and cosmetics.”

MedTechbloggen har tidigare redovisat FDAs prioriteringar för 2010 när det gäller medicintekniska produkter. Nedan ser du hur man beskriver sin prioritet 1,  ”Fully Implement a Total Product Life Cycle Approach”:

“Our public health responsibilities span the entire life cycle of medical devices, from early product development to long-term experience with the marketed device, from manufacturing to market use. At any stage of a device’s life cycle we must make well-supported regulatory decisions, taking into consideration all of the relevant information available to us.

To fully implement a total product life cycle approach, we will: (1) enhance and integrate premarket, postmarket, and compliance information and functions, in order to enable each part of our organization to meet current and anticipated challenges, and work together with a unity of effort toward our mission. To do so, we will: improve the quality and consistency of our science-based decision making by strengthening premarket review and aligning our use of scientific resources across the Center; make better use of information by enhancing our systems and processes for collecting, analyzing, and sharing information to support day-to-day Center needs; consider ways to better integrate our work across Offices by re-examining our organizational structure; and prepare to meet the demands of the future by addressing challenges associated with globalization and establishing mechanisms to incorporate new scientific information into our decision making. We will also: (2) improve guidance and regulation development, in order to convey current expectations and requirements to our external constituencies in a clear and timely manner; and (3) develop a cross-Center compliance strategy, in order to more effectively identify and address compliance issues across the total product life cycle.”

Inför 2010 har CDRH inom FDA arbetat fram fyra strategiska pririteringar för att effektivisera arbetet med registreringar och granskningar av medicintekniska produkter. Självklart kommer det också att påverka de svenska tillverkare som säljer produkter på USA-marknaden. En aktiv bevakning rekommenderas! Nedan hittar du FDAs prioriteringar. MedTechbloggen kommer längre fram med fördjupad info inom de olika prio-områdena.

Priority 1. Fully Implement a Total Product Life Cycle Approach

* Strategy 1.1. Enhance and Integrate Premarket, Postmarket, and Compliance Information and Functions
* Strategy 1.2. Improve Guidance and Regulation Development
* Strategy 1.3. Develop a Cross-Center Compliance Strategy

Priority 2. Enhance Communication and Transparency

* Strategy 2.1. Develop a Strategic Approach to Public Communication
* Strategy 2.2. Improve Internal Communications
* Strategy 2.3. Increase Transparency in Decision Making

Priority 3. Strengthen Our Workforce and Workplace

* Strategy 3.1. Recruit, Develop, and Retain High-Quality Employees
* Strategy 3.2. Leverage External Expertise
* Strategy 3.3. Establish Pathways for Resolving Differences of Opinion
* Strategy 3.4. Improve Internal Administrative Processes
* Strategy 3.5. Make CDRH’s White Oak Facilities More Workplace-Friendly

Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs

* Strategy 4.1. Foster Development of Medical Devices to Respond to Unmet Public Health Needs
* Strategy 4.2. Develop a Personalized Medicine Program

Under februari godkände FDA 183 st medicintekniska produkter enligt ansökningsförfarandet 510(k). Gissa hur många som kom från Sverige! Inte en enda en, 0 st. Varför vill inte svenska medicintekniska företag vara med på USA-marknaden? Kanske har vi inte några konkurrenskraftiga produkter. Det kan väl inte vara så att den svenska innovationsförmågan går på sparlåga?

Från UK har MedTechbloggen fått information som är viktig för dig som ska sätta medicintekniska produkter på USA-marknaden:

“An assessment of the US FDA’s 510(k) approval process for medical devices is expected to take place in May with the implementation of any changes being made by September this year, according to a top FDA official.”

FDA är på alerten och vill få synpunkter på hur man ska involvera medicintekniska produkter sprungna ur ny vetenskap. Har du vägarna förbi Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, titta in. Glöm inte anmäla dig innan:

“The Food and Drug Administration (FDA) is announcing a public meeting entitled: “Incorporation of New Science Into Regulatory Decisionmaking Within the Center for Devices and Radiological Health.”The purpose of the public meeting is to identify strategies and means for incorporating new science into the regulatory decisionmaking process within the agency’s Center for Devices and Radiological Health (CDRH). New science may include novel technologies or novel uses of existing technologies, evolving information and knowledge, or new methods to support decisionmaking. FDA is seeking input on a number of specific questions regarding how CDRH should anticipate and respond to new or evolving scientific knowledge in a manner that is consistent with our mission to protect and promote the public health, and requests comments on this topic.
Dates and Time: The public workshop will be held on February 9, 2010, from 8 a.m. to 5 p.m. Persons interested in attending the meeting must register by 5 p.m. on February 3, 2010.”