So, you’re petrified about talking to the U.S. Food and Drug Administration (FDA), right? Change your attitude!
The 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 its mission of promoting risk communication and health literacy within the business sector.
Health literacy describes the match between the regulatory information provided (below) and people’s capacity to find, understand and use that information. The purpose of the Strategic Plan for Risk Communication and Health Literacy (SPRCHL) is to clarify how the 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 for those individuals that 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 receive specific definition to product under concept before going down the classification path and market authorization clearance (510k) or premarket 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 the 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 the FDA proposes. FDA routinely allows plenty of time for public input and carefully considers these comments when it draws up a final rule. The 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 proposed rules and company-designed products to be a very positive experience in many of my inquiries and dealings with FDA professionals.
Walt Murray is a quality management and regulatory affairs professional with more than 32 years working with internationally recognized and highly-regulated companies, including J&J, Merck, Pfizer, Stryker, USANA and Del Monte Foods. A Six Sigma Black Belt, Murray is certified (CSSMB) in quality and environmental systems auditing (RAB/QSA/IATCA/IRCA), critical-thinking skills (CTS Facilitator) and process control (SPC/SQC). Having personally performed more than 350 1st/2nd/3rd-party audits for a variety of Fortune 500 life sciences companies, Murray has hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada (CMDR). Walt is based in Salt Lake City, Utah, and works as an independent expert as he supports regulated clientele for GMP, GLP, IVD, GCP and the cross-disciplinary development of MDSAP companies.
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