Every regulatory manual, plan, policy, procedure and document needs to be signed. That's easy enough to understand, these are legally binding documents after all. If an auditor is tracing a feature of your device through its history, you can bet she'll be looking at the signatures and dates.
And we have a long way to go. By early next year, FDA is set to release the final guidance on Laboratory Developed Tests (LDTs). They've been exercising enforcement discretion since 1976 and laboratory science has reached levels of complexity not even fathomed at the time.
Recognizing this complexity, and concerned about the distributed nature of the business (labs don't just serve patients a few doors up the hall, we serve patients across the nation and around the world), FDA has decided it is time to start enforcing the rules.
Of course, the industry is barely recognizable and the regulatory vocabulary and rules don't seem to fit the vernacular. Much of the angst in industry is actually rooted in the language FDA uses. How can it be a device, laboratorians say, when each test requires the application of intellect, experience, and even finesse by a qualified scientist? How can an LDT be developed entirely within a single lab when we must purchase primers, probes, tips, plates, and instruments from vendors? What will happen to supply lines when vendors are forced to sell only IVD-cleared reagents and instruments? What will regulation do to innovation and time to market?
These are all legitimate concerns, and will likely continue to be points of contention while FDA figures out what their final guidance will look like. Although scheduled for release by February 2015, many in the industry feel the final guidance is still a year or so out on the horizon.
Still, we know it's coming. What can laboratories do about it? Start by getting into the Quality Systems frame of mind. Study how 21 CFR 820 differs from CLIA and figure out ways to mold your current systems into a shape that better resembles FDA's idea of quality. The important thing is, don't panic. It doesn't have to be as painful as you think. PLC can help you develop an appropriate Quality System that works for you, so you can get back to what you do best--serving your patients.
Here is CLN's latest on the issue.