510(k) Templates | Customizable | Traditional 510(k) | Abbreviated 510(k) | Special 510(k)
Pursuant to Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), the submission of an eCopy is required. For FDA guidance document (“eCopy”), issued 12/31/2012, click .
On 12/31/2012, FDA issued Refuse to Accept Policy (“ for 510(k)s. In the guidance document, FDA explains the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.“)
To meet the requirements of both the eCopy and RTA policy for 510(k)s, it takes your significant time and efforts.