FDA asks UroMed for more information:
This article was originally published in Clinica
UroMed has received a request from the US FDA for more information on its Reliance urinary control insert, which has been granted expedited review status. An updated 510(k) was filed with the agency in August, after the FDA had requested additional information on the original application filed in December 1994. UroMed says it will file a response within 60 days, adding that it remains uncertain whether the FDA will accept the 510(k) or will require a PMA.