This is my dog Lucy “working” alongside me. As you can see, she was done with regulations for the day! She flat passed out asleep on top of the 21 CFR. I am sure we have all felt like Lucy from time to time – totally overwhelmed with a bunch of boring legalese. Well if this year hasn’t brought enough technical regulatory documents (i.e. – ISO 13485:2016, MDSAP, and the new EU MDR), the FDA has kicked it into high gear in a push to meet goals for the close of the fiscal year. FDA issued 20 new guidance documents since September 1! As you can see from this graph below, the push began in August 2017 with the re-authorization of MDUFA.These guidance documents covered a breadth of topics including pre-submission meetings, user fees, FDA review clock management practices, and much more. Needless to say, this much information can cause even the most tireless regulatory professionals to become weary.
The worst part is that FDA is unlikely to “slow their roll.” With MDUFA renewal and funding secure, FDA can focus resources to finishing its FY2017 list (they completed ~50% of their A-List and ~25% of their B-List) and tacking on a new round of guidance documents for FY2018.
In case you have lost track in the flurry of guidance document activity, click here to find the complete list of CDRH guidance documents published during FY2017. Also, if you click here you will find the outstanding items from the original FY2017 agenda.
These two lists will give you an idea on what to catch up on and then what to brace yourself for in FY2018. For 2018, we are committed to bring you the top 5 most important points out of the biggest hitting guidances.
The Lean team has put on another pot of coffee. We are here to help you out of the compliance quagmire.