Jan 8, 2015

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has formally launched a new database compiling all guidance documents pertinent to medical device manufacturers with products registered for sale in the US.

The new database allows users to search for FDA guidance documents using parameters including product type, date of issue, subject and draft versus final version. Although guidance documents officially only reflect US regulators’ “current thinking” on compliance issues related to 510(k), Premarket Approval (PMA) and other US market authorization pathways, it’s understood that registrants must typically follow these guidances as if they were final regulations. As such, the launch of this more centralized and accessible repository for various guidances should provide a valuable and time-saving resource for manufacturers looking for information that could help them anticipate compliance and registration issues for their devices.

The CDRH also plans similar database upgrades for product codes, 510(k)s and PMAs within the next few years. 


  • Stewart Eisenhart