FDA Launches Innovation Initiative

Citing the need to keep pace with medtech's rapidly advancing product design and development technologies, manufacturing processes, and information systems, FDA recently introduced a new Medical Device Innovation Initiative, which is intended “to make new medical devices available more quickly for patients.” According to the agency's announcement, one of the major objectives of the initiative is “to promote early interaction between FDA and industry to optimize review times and foster innovation.”

Commenting on the initiative, Andrew C. von Eschenbach, MD, acting FDA commissioner, said, “We must keep up with the rapid developments in science and technology to ensure that patients have access to the most advanced treatments available. By working with industry early in the evaluation process, we hope to foster development and speed up the approval of safe and effective innovative devices.”

In implementing the initiative, FDA's Center for Devices and Radiological Health (CDRH) will expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least-burdensome approach to clinical trials. The agency says the initiative builds on the device review program provided under the Medical Device User Fee and Modernization Act of 2002. Key aspects of the Medical Device Innovation Initiative include the following.

• Providing regulatory clarity through guidance development to increase the consistency and transparency of the agency's premarket review process.

• Investing in critical path to facilitate the availability of innovative medical devices in critical areas of unmet need, such as pediatrics.

• Conducting stakeholder outreach to improve ongoing communication among FDA, industry, patients, and clinicians for fostering medical device innovation and ensuring transparency.

• Conducting laboratory research to support efforts to improve the device development process, using research findings to assist agency decision-making and ultimately to help expedite the availability of products with innovative breakthrough technology.

• Implementing a quality review program for premarket submissions, in order to identify and apply best-management practices internally, reduce review times, ensure consistency among reviewers, and help product sponsors submit applications that efficiently demonstrate the safety and effectiveness of the device.

• Leveraging information technology (IT) solutions to improve patient safety and make the development process more efficient. CDRH is developing new IT systems that allow for better monitoring and tracking of premarket submissions and for improved communication and coordination among review teams.

• Expanding FDA's clinical and scientific expertise through the use of outside experts, to help the agency expedite the availability of new, cutting-edge technology so that CDRH remains current on the latest technological and clinical advances.

Daniel Schultz, MD, CDRH director, characterized the initiative as “an effort to evaluate the things that we want to do and the things we are already doing.” Speaking earlier this month at the annual meeting of the Medical Device Manufacturers Association (MDMA), Schultz said, “Some people look at the initiative and say, ‘This is nothing new. These are ongoing projects.' I would agree. But this puts it all together in a nice package.”

CDRH says the initiative is needed at this time because medtech innovations are continuing to transform healthcare delivery systems, while providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered. According to the agency, the initiative is intended to ensure that clinical trials, product reviews and approvals, and manufacturing processes, are conducted in the most efficient and effective ways possible. “Failure to do so now may stifle future innovation and delay patient and practitioner access to important safe and effective devices.”

As a first fruit of the innovation initiative's emphasis on guidance development, CDRH also announced the release of a new draft guidance document, Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials . The guidance provides recommendations on the use of Bayesian statistical methods in the design and analysis of medical device trials. It is intended to offer industry the option of using prior, legally available information about safety or effectiveness in a mathematically acceptable way to design more-efficient clinical trials, while still maintaining scientific rigor. Depending on the type of data available, this may lead to shorter, less expensive clinical trials.

CDRH director Schultz observed that “Although this guidance is not yet final, it is a very exciting move in the direction of expediting new technology to the public.”

Commenting on the initiative, Mark B. Leahey, executive director of MDMA (Washington, DC), said, “MDMA applauds FDA's efforts to encourage more communication among all stakeholders in the device development process, to ensure greater transparency, and to foster innovation, so that patients and caregivers have access to the safest, most-effective medical technology as quickly as possible.”

Complete details of FDA's innovation initiative are available from the CDRH Web site at www.fda.gov/cdrh/ocd/mdii.html. The full text of the CDRH guidance on the use of Bayesian statistics is available from the CDRH Web site at www.fda.gov/cdrh/osb/guidance/1601.html.

© 2006 Canon Communications LLC

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