Institute strengthens partnership with the FDA with mutual goal to bring innovative technologies to patients faster

by | Jun 1, 2017 | Fogarty Innovation, Mentoring, Policy

In just two short years, the Fogarty Institute’s first-of-its-kind educational pilot program with the FDA has blossomed into a successful, ongoing partnership that is being lauded on both sides for enhancing the understanding, communication and collaboration between entrepreneurs and regulators.

As a result of the collaboration, to date the Institute has hosted more than 50 reviewers, scientists and heads of departments with the aim of improving the efficiency of the device review process and accelerating disruptive technologies available to patients.

The relationship has proven to be beneficial for both sides, with the FDA more fully understanding the challenges inherent in device development, and Fogarty Institute entrepreneurs gaining a better understanding of how to navigate the regulatory process.

DICE develops educational materials to better navigate the regulatory environment

Recently the Institute hosted Elias Mallis, director of the FDA’s Division of Industry and Consumer Education (DICE), who shared information on his team’s role in educating and advising the medical device industry on how to best navigate the regulatory space. In turn, he was able to hear from the entrepreneurs who shared their needs and challenges. The feedback will help guide the division as it develops resources to meet the needs of the industry so they may more successfully engage the FDA on a variety of premarket and postmarket issues. The group discussed the concept of a “starter kit” and what content should be included to make it a useful resource to someone new to the medical device industry.

DICE educates a variety of medical device stakeholders, including regulated industry, consumers, researchers and others, through training materials such as workshops; CDRH Learn, a series of educational modules provided in a variety of formats; Device Advice, a narrative information written in plain language, and the traditional method of answering questions on a one-on-one basis. These topics cover the entire product lifecycle landscape, including the 510(k) program, clinical studies and the quality system.

The division’s efforts have been so successful that in the past year, more than 110,000 participants have reviewed the 125 CDRH Learn modules, and almost 38,000 stakeholder questions were answered by the group.

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