| 510(k) |
|
This abbreviation stands
for section 510(k) of the Federal Food, Drug and Cosmetic
Act which states that a person who intends to introduce
a devise into commercial distribution in the United States
is required to submit a premarket notification, popularly
called the 510(k), to the FDA at least 90 days before commercial
distribution is to begin. A manufacturer shall be issued
a letter of substantial equivalence and carry a unique
510(k) number to enable him to commence commercial distribution
of the device applied. 510(k) is not a quality program
and shall not be confused with ISO, GMP or ASTM. |
