The SBDC @ UCI Beall Applied Innovation Sheds Light on FDA Regulations

Past Tides
August 12, 2019 By Ethan Perez

Entrepreneurs, innovators and inquisitive minds convened at the Cove @ UCI Beal Applied Innovation to understand the Food and Drug Administration as it relates to biomedical products.

Hosted by the Small Business Development Center @ UCI Beall Applied Innovation, the workshop took attendees through the history of the FDA, the reasons behind regulations and resources available to those seeking FDA clearance or approval.

What is now known as the FDA began in the early 1900s and continued to expand its reach as numerous laws were enacted by Congress to regulate the quality, safety and efficacy of food and drug products. As part of the Department of Health and Human Services, the FDA is concerned with ensuring that products available to the public are not harmful and work as they are advertised.

Within the FDA are a number of centers dedicated to specific areas that require regulation. Three main centers deal with drugs, devices and biologics – or biomedical products: the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). Each center has specific regulations and guidelines to follow to evaluate and validate biomedical products.

“Obviously you need to regulate a tongue depressor differently than something like a heart valve,” said Molly Schmid, senior consultant with the SBDC with experience in bioinformatics, pharmaceuticals and health technologies. “The way the FDA and CDRH is organized is to say, ‘We have to classify medical devices into how risky they are if they are used,’ [and those are] class I, II and III – low risk, moderate risk, high risk.”

To determine the class – and, subsequently, the regulatory route – of a potential product is sometimes as simple as looking up similar products already on the market in the FDA’s database and seeing how they were classified.

For other tips on how to efficiently navigate regulatory processes, consultants at the SBDC @ UCI Beall Applied Innovation can direct interested parties to experts in the field. Furthermore, the FDA itself offers a free service under the Division of Industry and Consumer Education to answer questions and direct individuals to the right resources related to medical devices and radiation-emitting electronic products.

The SBDC @ UCI Beall Applied Innovation hosts numerous events on topics relevant to innovation and entrepreneurship. View the list of all upcoming events at the Cove.

SBDC Workshop FDA 101

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