The FDA updated the 515 program initiative webpage also known as reclassification of preAmendment Class III 510(k)s. Currently there are 26 Class III products going thru the 515 program initiative and you can view the status of the 515 project.
The FDA updated the 515 program initiative webpage also known as reclassification of preAmendment Class III 510(k)s. Currently there are 26 Class III products going thru the 515 program initiative and you can view the status of the 515 project.