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Making Your Voice Heard at FDA

FDA’s mission is to help people make informed decisions about FDA-regulated products. The FDA does this by communicating directly with product users and prescribers while giving guidance to industries to help them communicate about their products. This process helps FDA staff work toward FDA’s mission by promoting risk communication and health literacy within the business sector.

Health literacy describes the match between the information provided and people’s capacity to find, understand, and use that information. The purpose of Strategic Plan for Risk Communication and Health Literacy (SPRCHL) is to clarify how FDA can accomplish its mission by more effectively communicating the benefits and risks of FDA-regulated products to the target audiences including public and private sectors.  Communicating Risks and Benefits: An Evidence-Based User’s Guide (2017-2019) explains effective risk communication as essential to the well-being of any organization and those people who depend on it.  If a company has concerns about the description and use of its product, the process known as “513(g)” can be used to formally meet with experts from the FDA to give specific definition to product under concept before going down the classification path and market authorization clearance (510k), or pre-market approval (PMA). This is a strong way of starting a positive and supportive venue for FDA communication.  Once this conversation occurs, the product owner/promoter can move through formal application processes that are available on the FDA website (fda.gov) under the appropriate sector of product use.

Also, by law, anyone can participate in the rule-making process by commenting in writing on rules FDA proposes. FDA routinely allows plenty of time for public input and carefully considers these comments when it draws up a final rule.  FDA gathers public comments mainly through two channels: direct comments on proposed rules and formal petitions (FDA website: final rulemaking).  Transparency is a key objective of the FDA in all of its districts as well as at the “ivory tower” in Washington D.C.  I’ve personally found commenting on propose rules and company-designed products to be a very positive experience in many of my inquiries and dealings with FDA professionals.

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