Risk class and the route to market
The FDA sorts devices into classes according to risk, and the class largely determines how a device reaches the market. Many moderate-risk devices are cleared through a premarket notification showing they are substantially equivalent to a device already sold, while the highest-risk devices generally need premarket approval supported by clinical evidence. Novel devices with no suitable comparison may be able to use the De Novo pathway instead. Some low-risk devices are exempt from premarket review but still carry other obligations. Choosing a predicate device or a pathway is a strategic decision with long consequences for the product.
Duties that continue after launch
Clearance or approval marks the start of ongoing duties rather than the end of them. Manufacturers must operate under the FDA's quality system requirements, which the agency has recently aligned with the international standard ISO 13485. Certain adverse events and malfunctions have to be reported, and corrections or removals can carry reporting duties of their own. Changes to a device's design, labeling, or intended use may require a new submission, and the decision about whether one is needed should be documented. Inspections test whether all of this exists in practice and not just on paper.
Software, labs, and gray areas
Software that diagnoses or guides treatment can be a device, while some clinical decision support tools and general wellness products fall outside active FDA oversight under the agency's guidance. Laboratory-developed tests have been the subject of a long regulatory dispute, and the current position should be checked rather than assumed. Products sold abroad face separate requirements, including in the European Union, where a device generally needs a conformity assessment before it can be marketed. In a first conversation we look at the product's intended use and the claims made for it, because marketing language often determines whether something is a regulated device at all. From there we map which parts of medical device regulation apply and in what order.
