Providing Regulatory Clarity Through Guidance Development

CDRH will provide a clearer pathway for innovators by prioritizing guidance development to discuss regulatory requirements and review procedures to increase the consistency and transparency of its review process. Guidance documents related to specific innovative medical products currently under development include drug eluting stents, combination device/biologic products for cartilage repair, and genetic and pharmacogenomic tests. To address today's technological advancements, FDA also intends to release an intercenter guidance document on innovative combination products.

Investment in Critical Path
CDRH is collaborating with outside groups to facilitate the availability of innovative medical devices in critical areas of unmet needs, such as pediatrics. Such research includes developing anatomically and physiologically accurate adult and pediatric virtual circulatory systems that can quantify the maximum load and stress forces for certain vascular stent devices. Other examples include developing animal models to improve prediction of toxic effects of medical products on critically ill patients, as well as a new statistical model for predicting the effectiveness of implanted cardiac stents.
Conducting Stakeholder Outreach and Improve Communications

Effective and on-going communication among FDA, industry, patients and clinicians is essential for fostering medical device innovation and ensuring transparency. CDRH is stepping up its efforts to expand these kinds of interactions during product development and premarket review in order to improve its tools for communicating medical information to consumers and healthcare providers once products are marketed. These tools include workshops for industry, participation in professional conferences, and an improved process for issuing public health notifications.

Laboratory Research to Support Efforts to Improve the Device Development Process

CDRH is focusing its laboratory expertise and resources to address challenging scientific issues that arise in considering new medical device technologies. The research findings help inform agency decision-making and ultimately help to expedite the availability of products with innovative breakthrough technology. Examples include using CDRH laboratory expertise in experimental and computational fluid dynamics to evaluate a pediatric cardiac device, as well as CDRH's development of new models and methods for the assessment of computer-assisted diagnostic systems.

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