FDA Tips, Tricks, and Trends

Nelson Labs is hosting a Science of Sterilization Validation Seminar August 9-11 in Washington, DC, and I will be there presenting FDA 101: Tips, Tricks, and Trends. I hope you'll be able to join me, but if you can't, I want to share a bit about what I mean by FDA trends and why they're important. 

Looking at what's trending in any area can indicate what's important, what's up and coming, and where things are headed: looking at what's trending at FDA is no different. One way to decipher FDA trends is by looking at their proposed guidance documents for the year. Learning what they're working on tells us what's important at the agency and what their priorities are. In turn, we can extrapolate where industry focuses are: if FDA is putting out a guidance doc for a type of device or technology, it's generally because they're seeing it come up more frequently, and it needs to be addressed. 

CDRH publishes a list of guidance documents that it intends to release in each fiscal year, and 2016's can be found here

It's important to note that there is an "A-list" (guidance documents that FDA fully intends to publish that year), and a "B-list" (documents to be published as resources permit). A third list includes documents from 2006, 1996, 1986, and 1976 that should be reviewed for potential revisions at their ten year interval.  Whether every document on the lists actually gets issued depends on the agency's staffing, resources, and other factors such as guidance documents that need to be published for emergent public health issues and special control documents for de novo classifications. In part, the agency issues these lists in order to get feedback from stakeholders regarding which docs would be most helpful, thus increasing efficiency and making it a win for all involved. FDA also asks for industry feedback regarding the draft language, issues to consider, and general comments on guidance documents. 

This is a relatively new process for FDA that's part of a mutually beneficial agreement born of negotiations of the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114). In exchange for more funding from industry, FDA agreed to "meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly". As part of this agreement, FDA also promises to update their website routinely and "in a timely manner to reflect the Agency’s review of previously published guidance documents, including the deletion of guidance documents that no longer represent the Agency’s interpretation of, or policy on, a regulatory issue, and notation of guidance documents that are under review by the Agency."

In short, industry and FDA both win when they work together. I've got more tips, tricks, and trends in this vein in my presentation in DC. Join me!