The One Clear Message from the FDA? “We are Here to Help”

by | May 10, 2018 | Policy, Thought Leadership | 0 comments

Navigating through the Food and Drug Administration’s (FDA) policies, laws, pathways to approval and potential changes to existing regulations can be an intimidating process, especially for new or early-stage medical device startups. However, the organization has done an admirable job at proactively developing educational programs and reaching out to the industry and consumers.

Recently, the Institute once again hosted Elias Mallis, director of the FDA’s Division of Industry and Consumer Education (DICE), to help educate entrepreneurs in the regulatory aspects of bringing new clinical therapies to market.

He is particularly suited to address a number of different topics that startups are facing, given his 24-year tenure with the agency in a series of diverse roles that include branch chief, engineer and policy team member. He has also served in many divisions of the FDA, including OBGYN, cardiology, gastroenterology and other clinical fields.

As Elias began his presentation, he shared a quote from the late Ronald Reagan, “I’m from the government and I’m here to help.” Fortunately, his words do indeed ring true: Yes, FDA team members are regulators, but they are also patients and consumers – in other words, we are all on the same team and the same side.

“The aim is to help understand each other’s perspective to ultimately ensure that products and devices get to patients,” he said.

Available Resources Pave the Way

DICE’s vision statement is to ensure accurate, timely, targeted and useful information, reflective of current policy and delivered in a variety of formats for different preferences. To that end, the agency has compiled a library of free online resources to better serve thousands of stakeholders each month. These include:

  • CDRH Learn: These video-based tutorials cover a range of topics and are presented in formats that include webinars, how-to videos and audio recordings. Clocking in at approximately 20 minutes, they are the perfect length for diving in and out as time allows. The program’s popularity is evident in the fact that they amassed nearly 130,000 views in 2017 – approximately 350 a day. The agency is constantly developing new expert content that will be of interest to entrepreneurs.
  • Device Advice: These regularly updated texts aim to explain guidance in plain language for both pre- and post-market regulatory information. Again, the focus is on user-friendliness, and visitors with additional questions can call the division at (800) 638-2041 – average wait time is one minute, with most questions answered within five. Email ( is another option, with average answer time of two days.

In 2016, the advice within the 30 regulatory categories was viewed nearly 125,000 times.

  • Workshop Series: While the agency devotes time to answering calls and emails, it also puts an emphasis on proactively reaching out to the industry. One example is the Regulatory Education for Industry (REdl) Spring Conference, covering both drugs and devices, which will take place on May 15-16 in Burlingame, Calif., and also be delivered via live webcast. A recording will be available online for up to six months.

In-house experts are constantly developing additional topics of interest to both pre- and post-market audiences, often based on the questions they receive at such events.

The Agency is There to Help

All in all, in 2017 the agency answered 21,189 and 12,245 emails, for an average of 139 contacts a day. And the “help” was reciprocal: As the agency studied trends in the inquiries and reactions to new policies, they could determine where there was confusion or where better education was warranted.

Overall, Elias sees a bright future for the program, which has greatly evolved since he joined in 1994.

While it can be challenging to keep up with the changes, he says they are entering an era of aiming to pursue smart regulation with very strategic priorities and trying to leverage information without causing a high level of burden to the sponsor to collect the information previously needed.

“We are striving for the least-burdensome pathway to submit the required information to get to the finish line through offering a variety of tools, as well as a choice in terms of data collection,” he said, adding that DICE is anonymous and therefore a safe space for innovators.

By navigating through the official channels to seek answers to regulatory pathway questions or evidence of collection, entrepreneurs can get advice before exhausting a lot of time in the wrong direction.

About the Institute’s FDA Fellowship program

Now in its third year, the FDA Fellowship program is flourishing. Since its inception, the Institute has hosted more than 75 reviewers, scientists and head of departments to enhance the understanding, communication and collaboration between entrepreneurs and regulators – all to shorten the time to bring new technologies to patients.

The feedback from the agency has been very positive, and the application process has become very competitive, with 80 individuals applying for three open spots during the last Fellowship round. FDA employees are invited to spend time immersed within the Institute, learning first-hand the challenges involved in developing innovative new medical technologies. At the same time, our companies gain unparalleled access to FDA participants and develop a much deeper understanding of the U.S. regulatory process.

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