Demystifying the FDA: Five Steps to the U.S. Market

Every device programme meets the same question eventually, and most meet it late: what is the FDA actually going to require of this product. The answer is never in the hardware. It sits in the claims, the intended use and the patient population, which is why a desk lamp can be a medical device and an incontinence product is regulated for an adult and not for an infant. This hour works it upward from the classification system, then walks the five steps to a US submission and prices each one: $7,163 for a small business 510(k), $47,775 for a De Novo, a PMA fee near $160,000, and a timetable running from 150 days to more than two years.

In this MedTech Leading Voice session, Michelle Lott, RAC, Principal and Founder of leanRAQA and an industry representative on FDA's Good Manufacturing Practices Advisory Committee, takes the classification system apart with its controls and exemptions, then walks the five steps to market: defining the product, verifying that it is a device at all, determining classification and pathway, developing valid scientific evidence, and supporting a premarket submission. The worked examples carry it, from the desk lamp to the diapers to the mask that changes product code the moment an antimicrobial agent joins it, and she closes on the mistake that costs the most, bringing regulatory in after the product is built.