QSIT: Another Regulatory Acronym Bites the Dust
Amid the worst blizzard in the US since the last worst blizzard, the U.S. FDA quietly announced the demise of the medical device
Guide to Inspections of Quality Systems, acronymized QSIT well over two decades ago, back when AI was fake and scary as opposed to today when it is real and powerful and maybe scary.
QSIT blew onto the regulatory scene in 1999 as a product of FDA’s Quality System Inspections Reengineering Team, which included folks from the Office of Regulatory Affairs (ORA—another dead acronym) and the Center for Devices and Radiological Health. The Guide to Inspections of Quality Systems was complete with a funny-looking logo which seemed to be made with Print Shop Deluxe. If you look up some old PDA Letters from that era, you will find a striking similarity in the lack of good logo design, but then, I digress.
On the brief drive-by to the Dustbin of Acronym History, FDA explained:
On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850. After February 2, 2026, the FDA will no longer use the following documents: Inspection of Medical Device Manufacturers (7382.845) and Medical Device PMA Preapproval and PMA Postmarket Inspections (7383.001). The updated program aligns with Quality Management System Regulation (QMSR) requirements, describes the QMSR inspection process, and updates regulatory procedures and program contacts. (1,2)
No doubt, this change took no one by surprise, so this article should be viewed for what it is: Homage to the dead acronyms that the regulatory professionals and journalists loved to use and possibly abuse in our written reports and treatises about FDA policy.
I’m proud to declare that after 80 years, PDA is still an active and well-known acronym, though not really on point with FDA acronyms. One FDA acronym that isn’t going anywhere any time soon is CGMPs (even if you drop or lowercase the “C” and drop the “s”).
QSIT might headline this ode to deceased acronyms, but it is not necessarily the most famous. Here are some I tracked down in the dustbin, and if you have a favorite disused acronym, please send it in at publications@pda.org, subject: FDA Dustbin of Acronym History.
A Brief Listing of the FDA Dustbin of Acronym History
- QSIT: Quality System Inspection Technique
- ORA: Office of Regulatory Affairs
- QSR: Quality System Regulation (currently being phased out in favor of QMSR)
- CPI: Critical Path Initiative
- BACPAC: Bulk Actives Post-Approval Changes
- AMPAC: Analytical Methodes Post-Approval Changes
- UDI: Unapproved Drug Initiative
- EAP: Expedited Access Pathway
- CSV: Computer Systems Validation (a zombie as this term is still widely used though FDA has changed focus to Computer Software Assurance—CSA)
- OTRR: Office of Therapeutics and Review (CBER)
- OCET: Office of Counter-Terrorism and Emerging Threats
- ORSI: Office of Regulatory Science and Innovation
- CANDA: Computer-Assisted New Drug Application
Change comes often to the U.S. FDA, but one thing will never change about it or any government agency: the never-ending death and birth of new acronyms. I like to call it the Regulatory Affairs Acronym Lifecycle, or RAAL. (3)
References
- https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/center-devices-and-radiological-health-cdrh-compliance-programs?utm_source=substack&utm_medium=email
- http://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/media/80195/download?utm_source=substack&utm_medium=email
- Dead acronyms do not imply dead programs. Many of the programs underlying these disused acronyms evolved over time, birthing new acronyms. This article is just a tongue-in-cheek review by someone who has written about FDA initiatives for 30 years.