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Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review


Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review


To encourage innovation and provide patients with access to the latest safe and effective medical technologies, we continually strive to make the device development and regulatory review process more modern, science-based and efficient. A key feature of these efforts is early and more thorough engagement with innovators to help them meet the FDA’s science-based requirements in a way that allows companies to bring safe, effective modern devices to patients as soon as possible. This approach is one aspect of what we refer to as “least burdensome.”

As FDA commissioner, I’m fully committed to implementing these principles. I agree with the findings of a new GAO report that evaluation of the appropriate implementation of the least burdensome requirements is needed. An effective and consistent least burdensome approach is essential for evaluating novel devices under FDA review as well as accommodating iterative improvements to existing devices already on the market. The FDA has taken steps to apply this approach since Congress first enacted the least burdensome provisions in 1997, which have already resulted in benefits to public health. We’ve recently taken new steps to further advance and expand these goals.

For example, we’ve been expanding the use of “real world data” gathered as part of clinical care, such as electronic health records and patient registries. Through a total life cycle approach to device regulation that includes pre-market as well as post-market data collection, the use of real world data can better inform our understanding of device benefits and risks, and can reduce the time and cost of bringing safe and effective new devices to patients. Last year, we provided new draft guidance on the Breakthrough Device Program to encourage earlier and more frequent interaction between the FDA and manufacturers in order to help bring state-of-the-art technologies to market faster. We also qualified the first medical device development tool to provide more efficient and accurate ways to measure benefits and risks early in the process of building and testing a new medical device.

As part of our commitment to the least burdensome approach, the agency has already trained more than 90 percent of its staff in the center for devices on these requirements. We plan to complete an audit of this training by June and then periodically audit our application of the least burdensome approach thereafter.

We also recently issued a new draft guidance that clarifies the guiding principles for how the FDA intends to implement and go beyond additional “least burdensome” provisions enacted by Congress in the 21st Century Cures Act, including assessing the minimal amount of information necessary for assuring the safety and effectiveness of new devices. This will allow innovations that benefit patients to reach them more efficiently by collecting the right kind of data at the right time, while maintaining our standards for device review and approval.

At the same time, across the medical product centers, we’ve outlined some different pathways for manufacturers to engage the agency earlier in the development process. We have engaged in prior analysis of the factors that help predict regulatory success. We know from that research that very early engagement with the FDA, even preclinical meetings, can give product developers important assistance.

For example, with some of these new modalities like gene therapy and regenerative medicine, where there’s so much uncertainty, we encourage biotech firms to engage with us early to get feedback on how to design early-stage development programs. Similarly, to keep pace with evolving 3-D printing technology and to encourage and support innovation in this field, the FDA has led the world in advancing efforts to provide a comprehensive policy framework to help guide manufacturers and a more efficacious pathway to getting state-of-the-art medical products into the hands of patients and health care providers.

As we work to encourage innovation and advancement in the market, patient safety is and will remain a cornerstone of our regulatory commitment. We’re continuing to evaluate all aspects of our policies, including least burdensome approaches and post-market data collection, to ensure that we’re protecting consumers and advancing the FDA’s gold standard for regulatory safety and effectiveness, while promoting beneficial innovation.

I want to make clear that our stringent review standards will not change. Patients must continue to trust in the medical products that we review for safety and effectiveness before they go on the market. In the coming months, we’ll share more information on our new efforts to improve the safety of medical devices. We’ll be releasing a new medical device safety action plan as part of our 2018 Strategic Policy Roadmap. We’ll also advance new ways to provide more transparency to patients who want to be better informed about the risks and benefits of a device before determining whether to use it for a crucial medical treatment.

Consistent with the goals of the least burdensome approach, the FDA has utilized risk-based compliance strategies through the implementation of a variety of new policies. Our general wellness guidance, for example, clarified for industry that we don’t intend to examine low-risk products that are part of the fitness/wellness industry. Under this policy, we focused our attention on higher risk products, while making the development process more efficient. We’re also aiming to provide consumers with easier access to reliable diagnostic information. We’re considering, in some narrow cases, complementary and voluntary new programs to encourage product developers to seek the benefits of FDA review through more efficient third-party validation and a new “Pre-Cert” review process.

As part of this commitment to modernize the agency’s approach to medical device regulation, we announced our intention to propose an alternate approach to the traditional 510(k) clearance pathway, which will involve the use of modern, science-based consensus standards and FDA-developed performance criteria as a way to evaluate iterative changes in well-understood technologies.

Applying the least burdensome concept to medical device regulation has been fundamental to our mission of protecting patients while promoting access to innovations that can help patients improve their health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.