Katrina’s Blog™

Abbreviated 510(k)sThe third type of premarket notification available under the New 510(k) paradigm is the Abbreviated 510(k). This notification was originally authorized for use on a modified device when there exists an issued guidance, an established special control...

The Special 510(k)Under the New 510(k) paradigm (the guidance was published in 1998, so it’s hardly that new), there are 3 ways that sponsors may file a premarket notification for their device. Page 11 of that guidance document contains a flow chart that may help...

For Ebola Virus Detection in Response to the Latest OutbreakThe FDA published a notice in the Federal Register on 13FEB2019 authorizing the emergency use of an in vitro diagnostic device (IVDD) manufactured by Chembio Diagnostic Systems, Inc. This authorization is a...

The 510(k) Pathway for Premarket Notification The 510(k) pathway is a premarket approval application process authorized under section 510(k) of the FD&C Act. This type of application is required for all classes of devices that either don’t require a PMA...

Classification Leads to PathwayIt can be pretty confusing to look at the medical device regulations to figure out how to submit the appropriate documentation for review, particularly in the light of the many new device programs and guidance being announced monthly....