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Questions and Answers about the Medical Device Innovation Initiative

February 8, 2011

General Questions and Answers on the Medical Device Innovation Initiative

  • What is the Medical Device Innovation Initiative?
  • Why has CRDH launched the Medical Device Innovation Initiative?
  • How much of CDRH's resources are devoted to the Medical Device Innovation Initiative and to devices in the Innovation Pathway?
  • How will the Medical Device Innovation Initiative promote and support investment in new technology?
  • How does the Medical Device Innovation Initiative tie into other FDA initiatives, such as the Critical Path, Medical Countermeasures, Advancing Regulatory Science Initiative, and the 510(k) Plan of Action?
  • What input is CDRH seeking from stakeholders about the Medical Device Innovation Initiative?
  • What input is CDRH seeking from stakeholders about Medical Device Innovation?
  • Is there a goal for implementing the steps proposed in the Medical Device Innovation Initiative white paper?

Question and Answers on facilitating the development of regulatory evaluation and innovative medical devices

  • What kinds of devices may be considered for the Innovation Pathway?
  • Will the Medical Device Innovation Initiative shorten the review process?
  • How is the Innovation Pathway different from the 510(k), Premarket Approval Application (PMA), or other regulatory paths to market?
  • Are there any products in the Innovation Pathway now?
  • When will CDRH consider other devices for the Innovation Pathway?
  • What is the de novopathway?

Questions and Answers on strengthening the U.S. research infrastructure and promoting high-quality regulatory science

  • What is regulatory science?
  • What is a clinical test center?
  • How would a voluntary third-party certification program for U.S. clinical test centers strengthen the U.S. research infrastructure and promote high-quality regulatory science?
  • How would a certified clinical test center facilitate the development and testing of innovative medical devices?
  • What criteria would a certified clinical test center have to meet?
  • How would a core curriculum for medical device development increase the quality and capacity for innovative medical device development and testing in the U.S.?
  • How will CDRH make data generated from medical device research conducted in foreign countries available for use in support of U.S. device marketing applications?
  • How will CDRH stay actively engaged in regulatory science research?

Questions and Answers on preparing and responding to transformative innovative technologies and scientific breakthroughs

  • What is horizon scanning?
  • What is the CDRH Network of Experts?

General Questions and Answers on the Medical Device Innovation Initiative

What is the Medical Device Innovation Initiative?
The CDRH Medical Device Innovation Initiative proposes actions that CDRH could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices safely and based on sound science.  These actions include:

Facilitate the development and regulatory evaluation of innovative medical devices by:

  • Establishing the Innovation Pathway – a priority review program pioneering medical devices; and,
  • Streamlining the de novo pathway.

Strengthen the U.S. research infrastructure and promote high-quality regulatory science by

  • Establishing a voluntary third-party certification program for US clinical test centers;
  • Creating a publicly available core curriculum for medical device development and assessment;
  • Leveraging device experience and data collected outside the United States; and,
  • Advancing regulatory science for medical devices through prioritizing scientific research, establishing public-private partnerships, collaborating with other government agencies, and holding public workshops.

Prepare for and respond to transformative innovative technologies and scientific breakthroughs by:

  • Enhancing CDRH’s current horizon scanning process by adopting emerging horizon scanning methods, seeking public input to identify important and innovative medical device technologies as they arise, and periodically reporting its horizon scanning findings to the public; and
  • Developing a Network (or Networks) of Experts to serve as a resource to assist in addressing scientific questions about emerging technologies with which our reviewers might not be immediately familiar.

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Why has CDRH launched the Medical Device Innovation Initiative?
Facilitating innovation is a top priority for CDRH.  As part of its 2011 Strategic Plan, CDRH set goals to proactively facilitate innovation to address unmet public health needs.  In 2010, CDRH and the Council on Medical Device Innovation held a workshop to identify areas of need for new devices and understand the barriers developers face.  Last month, CDRH  launched a 510(k) Plan of Action, which includes steps CDRH will take to foster continued innovation and evolution of existing technologies and to improve the transparency and predictability of our most common review pathway.

CDRH recognizes that transformative innovative devices typically present new scientific and regulatory challenges.  The Innovation Initiative supports the development of innovative products by addressing some of the barriers that can impede a product’s timely progress to market.

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How much of CDRH's resources are devoted to the Medical Device Innovation Initiative and to devices in the Innovation Pathway?
As part of this Medical Device Innovation Initiative, CDRH is proposing additional actions the Center could take to encourage innovation, streamline regulatory and scientific device evaluation, and expedite the delivery of novel, important, safe and effective innovative medical devices to patients.

Because improving the predictability of our premarket review programs is our number one priority, CDRH will proceed in a manner that does not delay the implementation of critical actions to reduce uncertainty and that does not adversely impact our premarket review performance. Instead, we will implement the Innovation Initiative to the extent practical given current resources, and would consider expanding the Initiative should additional resources become available.

While it is critically important to take steps to facilitate the development of transformative innovative devices, we also recognize the importance of meeting our commitments under MDUFA.  Therefore, the number of devices that we would be able to accommodate under the Innovation Pathway would depend on available resources.  We would closely monitor our resources so that our performance and commitments for the review of other devices are not adversely affected, thus avoiding unintended consequences for devices reviewed under other pathways.

How will the Medical Device Innovation Initiative promote and support investment in new technology?
Lack of a transparent, predictable path to market is a significant barrier to innovation. Without a predictable path to market, it is difficult for innovating companies to attract investors and estimate costs. As part of this Medical Device Innovation Initiative, CDRH is proposing additional actions the Center could take to encourage innovation, streamline regulatory and scientific device evaluation, and expedite the delivery of novel, important, safe and effective innovative medical devices to patients.

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How does the Medical Device Innovation Initiative tie into other FDA initiatives, such as Critical Path, Medical Countermeasures, Advancing Regulatory Science, and the 510(k) Plan of Action?
CDRH’s Medical Device Innovation Initiative aligns with goals of the FDA-wide Critical Path and Medical Countermeasures Initiatives by targeting innovation in the areas of unmet public health needs, bioterrorism, and infectious disease.  The Medical Device Innovation Initiative will focus on the unique challenges of the medical device industry, helping product developers navigate the regulatory pathway to get innovative devices to patients more efficiently.

The Medical Device Innovation Initiative shares the same goals as FDA’s initiative on Advancing Regulatory Science for Public Health, including strengthening the U.S. research infrastructure to help make the evaluation and approval process more efficient, helping to deliver safe new products to patients faster, and strengthening the ability to monitor product use and improve performance, thus enhancing patient outcomes.  Under the Innovation Initiative, CDRH would advance regulatory science by establishing a voluntary third-party certification program for U.S. clinical test centers specializing in medical device evaluation and creating a publicly-available core curriculum for medical device development.

Earlier this year, CDRH released its 510(k) Plan of Action, which focuses on increasing transparency and predictability of the 510(k) program and fostering continued innovation and evolution of existing medical device technologies.  The Medical Device Innovation Initiative outlines additional actions CDRH would take to accommodate the scientific and regulatory challenges presented by transformative innovative devices and to expedite the delivery of safe and effective innovative products to patients, specifically focusing on the premarket approval and de novo applications, which likely represents more innovative Class II devices.

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What input is CDRH seeking from stakeholders about the Medical Device Innovation Initiative? 
CDRH requests public comments on the Medical Device Innovation Initiative in general, as well as on the following specific questions and topics:

  • What should be the eligibility criteria for the Innovation Pathway?
  • How should CDRH determine what types of technology should be allowed into the Innovation Pathway and at what point should they no longer be accepted as innovative products? 
  • What are the appropriate timeframes for review of submissions under the Innovation Pathway? 
  • What should be the criteria for clinical test center certification?
  • What are examples of candidates for inter-agency or public–private partnerships to foster medical device innovation?
  • What other actions should CDRH take to facilitate the development, assessment, and regulatory review of innovative medical devices while assuring their safety and effectiveness?

CDRH is holding a Medical Device Innovation Initiative Public Workshop on March 15, 2011 and has opened a public docket to gather input on these questions and topics.

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Is there a goal for implementing the steps proposed in the Medical Device Innovation Initiative white paper?
The Medical Device Innovation Initiative is part of CDRH’s 2011 Strategic Priorities.  CDRH will hold a public meeting on March 15, 2011, and will continue to solicit feedback on the Innovation Initiative through a public docket until April 11, 2011.

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Question and Answers on facilitating the development of regulatory evaluation and innovative medical devices

What kinds of devices may be considered for the Innovation Pathway?
These devices would be radically different from any legally marketed medical device in the United States in their underlying technology or manner of use, and be designed to meet at least one of the following criteria:

  1. significantly improve upon currently available treatments or diagnostics for life-threatening or irreversibly debilitating diseases or conditions;
  • treat or diagnose a disease or condition for which no approved alternative treatment or means of diagnosis exists;
  • address an unmet public health need as identified by the Council on Medical Device Innovation (CMDI); or
  • address an issue relevant to national security such as vaccine development and medical counter measures.

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Will the Innovation Pathway shorten the review process?
The Innovation Pathway includes a number of key features designed to minimize delays that can occur when pioneering devices raise novel and challenging scientific questions. By front-loading critical aspects, such as identifying appropriate clinical endpoints and key scientific questions, and seeking advice from external experts, CDRH can provide a more timely and efficient regulatory review process.  Given significant senior management involvement and review team involvement throughout the device development process, CDRH proposes a review time frame of 150 days – which is approximately half the time it takes to review most PMAs.

Enrollment in the Innovation Pathway would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and determine their appropriateness for marketing.  Instead, the Innovation Pathway would recognize the challenges of developing transformative innovative devices and increases the commitment of Center resources to their development and evaluation.

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How is the Innovation Pathway different from the 510(k), Premarket Approval Application (PMA), or other regulatory paths to market?
The Innovation Pathway is not a new regulatory pathway.  It is a special program that gets CDRH involved earlier in the device development process to help identify issues early on that may result in delays during regulatory review and to help shepherd qualifying devices through the regulatory process.  We anticipate that most devices that qualify for Innovation Pathway will be submitted for review as PMAs or through the de novo process.

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Are there any products in the Innovation Pathway now?
Although the Innovation Pathway is a proposal for which CDRH seeks public comment, the Center has accepted a pilot submission into the program: a revolutionary brain-controlled upper-extremity prosthetic designed to restore near-natural arm, hand and finger function to patients suffering from spinal cord injury, stroke or upper-extremity amputation.  The arm system, funded by the Defense Advanced Research Projects Agency (DARPA), will use a microchip implanted on the surface of the brain to record neuronal activity and decode the signals to actuate motor neurons that control the prosthesis.

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When will CDRH consider other devices for the Innovation Pathway?
At this time, we are not accepting applications for the Innovation Pathway. After we receive public feedback on the Innovation Initiative proposals, we will announce the finalized process for submitting applications to the Innovation Pathway.

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What is the de novo pathway?
The de novo classification process was created to provide a mechanism for the classification of certain lower-risk devices for which there is no predicate.  The de novo classification process is intended to apply to lower-risk devices that are classified into class III through the 510(k) process.  The de novo process is most applicable when the risks of a device are well-understood and appropriate special controls can be established to mitigate those risks. 

The de novo is an underutilized path to market, but can be important in bringing low- to moderate-risk devices to patients faster. CDRH is taking steps to clarify the criteria for de novo eligibility and to streamline implementation of the de novo process.  CDRH will issue draft guidance on the de novo pathway by Sept. 30, 2011.

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Questions and Answers on strengthening the U.S. research infrastructure and promoting high-quality regulatory science

What is regulatory science? 
Regulatory science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.
To be most effective, advances in regulatory science must be fully integrated into the entire product development process. Outreach and collaborative efforts are integral to predicting the failure or success of new discoveries and technologies early in development, reducing product development costs. Advances in regulatory science will help make the evaluation and approval process more efficient, helping to deliver safe new products to patients faster and strengthening the ability to monitor product use and improve performance, thus enhancing patient outcomes.

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What is a Clinical Test Center?
A clinical test center is a research facility that conducts research on investigational medical products. 

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How would a voluntary third party certification program for U.S. clinical test centers strengthen the U.S. research infrastructure and promote high-quality regulatory science?
Certifying clinical test centers would strengthen the U.S. research infrastructure by helping sponsors to more easily identify high quality test centers for medical device development and assessment, while providing greater assurance of patient safety.  Certified test centers would bring together the key scientific expertise required to more efficiently and safely develop and test innovative medical devices consistent with the iterative nature of device design, testing, and redesign.

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How would a certified clinical test center facilitate the development and testing of innovative medical devices?
Ideally, these test centers would be able to identify and correct device shortcomings quickly, thereby minimizing patient exposure to significant and unnecessary safety risks.  In addition, because of their expertise and established safety records, CDRH would consider permitting these centers to conduct first-in-human studies.  In some cases, test centers may be able to acquire a “Center of Excellence” distinction related to expertise in specific areas (such as diabetes, wireless technologies, etc.).

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What would be the criteria for a certified clinical test center?
Certain criteria would include:

  • The center has access to necessary device development expertise through a formal relationship with a medical device design and engineering “academic” (i.e. non-industry) center;
  • The center has a robust clinical program and diverse expertise to anticipate and manage medical issues that may arise during the course of clinical studies, particularly for those sites participating in early clinical trials and/or studying implanted devices;
  • The center has a robust safety monitoring system, such as timely and effective reporting of adverse events, for significant risk studies; and
  • The center demonstrates expertise in clinical trial design and conduct as well as human subject protection and data integrity training, expertise, and oversight consistent with Good Clinical Practices.

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How would a core curriculum for medical device development increase the quality and capacity for innovative medical device development and testing the United States?
Currently there are few institutions that possess all the necessary expertise to design, test and clinically evaluate devices, identify the root causes of adverse events and device malfunctions, develop iterative device designs, and navigate the regulatory process.

To facilitate the widespread availability of educational programs in device development and assessment to train the next generation of innovators and help keep the U.S. the leader in medical device innovation, CDRH would work with academia, industry, and the health care community to develop a publicly-available core curriculum covering the areas of device design and engineering, pre-clinical testing, clinical evaluation, regulatory processes and post-market monitoring.

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How will CDRH make data generated from medical device research conducted in foreign countries available for use in support of U.S. device marketing applications?
CDRH recognizes that a significant portion of medical device research occurs outside the United States, and CDRH accepts foreign clinical data that complies with our regulatory criteria.

Historically, the applicability of data developed outside the United States has been limited due to key deficiencies, namely, insufficient quality and/or data integrity, and lack of sufficient demographic and clinical information to determine applicability to the U.S. population.  As part of its Innovation Initiative, CDRH will develop a guidance document describing the Center’s recommendations for criteria and circumstances under which foreign test centers should develop data to be used in support of U.S. device marketing applications.

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How will CDRH stay actively engaged in regulatory science research?

In addition to a broad portfolio of research and training activities, scientists in CDRH’s Office of Science and Engineering Laboratories (OSEL), are also working on a number of projects to strengthen regulatory science, including:

  • Novel imaging techniques to produce real-time, high-resolution cross-sectional medical images of tissue with a resolution of only a few microns.
  • Light therapy for neurostimulation, which will avoid the malfunction of electrodes that commonly occurs with long-term electrical stimulation; and
  • High intensity focused ultrasound, which is a minimally invasive therapy to stop internal bleeding and ablate pathologic tissue.

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Questions and answers on preparing for and responding to transformative innovative technologies and scientific breakthroughs

What is horizon scanning?
Horizon scanning is an approach that reviews important scientific literature and accounts for public health needs as well as considers technologies funded by other government agencies, input from manufacturers and other stakeholders with knowledge of the medical device industry, and information from various other sources.  This information helps CDRH anticipate and prepare for emerging device technologies by focusing our hiring and contracting, staff education, and research efforts in these areas.

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What is the CDRH Network (or Network) of Experts?
With the assistance of scientific experts outside the Center, our reviewers can obtain additional perspectives, gain knowledge, and ultimately make better informed decisions, provide clearer expectations for data requirements, and more easily address other scientific issues that arise during the regulatory review process.  In addition, engagement with external experts supports a culture of continuous scientific learning, promotes professional staff development, and provides the flexibility needed to review innovative devices in a timely manner.

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