News coverage tends to use approval for anything that reaches the market. In United States medical device regulation the term has a narrow meaning, and most devices arrive by a different route.
Devices are sorted by risk class
Devices are assigned to one of three classes according to the risk they present and the controls needed to provide reasonable assurance of safety and effectiveness.
The lowest class covers items such as bandages and manual instruments, many of which are exempt from premarket submission entirely.
The highest class covers devices that sustain life or present potential unreasonable risk of illness or injury, including implanted cardiac devices.
Clearance rests on comparison
The most common pathway allows a manufacturer to show that a new device is substantially equivalent to a legally marketed predicate device in intended use and technological characteristics.
A successful submission results in clearance to market. It does not necessarily involve new clinical trials, because the argument is about equivalence rather than fresh demonstration of effect.
Predicates can themselves have been cleared against earlier predicates, producing chains of equivalence extending back through generations of a device family.
Approval requires its own evidence
Premarket approval applies to the highest-risk class and requires the manufacturer to supply valid scientific evidence, typically including clinical data, that the device is safe and effective for its intended use.
Manufacturing processes and labeling are reviewed as part of that submission, and changes afterward may require supplemental review.
This is the only device pathway to which the word approval properly applies.
Other routes fill the gaps
A separate pathway exists for novel low- and moderate-risk devices with no suitable predicate, creating a classification the next similar device can then reference.
Emergency use authorization is a distinct legal mechanism available during declared emergencies, permitting use based on a different standard than approval and revocable when the declaration ends.
Humanitarian pathways address devices intended for very small patient populations, where conventional trials are impractical.
Why the distinction matters to a reader
A cleared device has met a comparison standard, and a marketing claim describing it as FDA approved is using the wrong word for what happened.
Registration and listing, which simply record that a facility and product exist, carry still less meaning and are sometimes cited as though they were an endorsement.
Whether a particular device suits a particular patient is a clinical judgment that the regulatory pathway does not answer, and belongs with the treating physician.