Small Business Support
The FDA provides tools and resources to support small businesses. The agency has established the Division of Industry and Consumer Education (DICE) within the Center for Devices and Radiological Health (CDRH), as well as Small Business Assistance Programs in the five FDA regional offices, and the creation of small business assistance offices in each of the Centers. These units “provide technical assistance to small companies, hold exchange meetings to hear the views and perspectives of small businesses, conduct educational workshops, develop informational materials, and provide an accessible, efficient channel through which small businesses can acquire information from the FDA.”[1]
The DICE (within CDER) answers questions from industry and consumers. DICE develops resources for the FDA website, which helps to educate the medical device industry with respect to FDA regulations and policies.[2] CDRH supports Device Advice, a webpage and centralized resource that explains medical device laws, regulations, guidance, and policies. The CDRH provides multimedia industry education through CDRH Learn.
The CDRH’s Small Business Program determines if a business is qualified and certified as a “small business,” making them eligible for a reduced fee for some types of CDRH submissions. A small business is one whose gross receipts and sales total less than $100 million in the most recent tax year. Small businesses may be eligible for a reduced fee for the following types of applications: Premarket Notification (510(k)), De Novo request, Premarket Applications (Premarket Approval Application, Biologics License Application, Product Development Protocol), Premarket Report, PMA/BLA Supplements and PMA Annual Reports, and 513(g) request for classification information. A small business is eligible for a “first premarket application/report” fee waiver if the business (including any affiliates) has gross receipts or sales totaling no more than $30 million.[3] More information about reduced fees for small businesses is available here.
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