Although the regulatory burden is greatly reduced for Class I devices, manufacturers of Class I devices are still required to register their establishment with FDA, list their device(s) in the FURLS, and maintain general controls.
In FDA speak, the phrase “failure to define” is code for “your organization has screwed up and missed something!”
The seizure process is just a tiny bit more complex than having U.S. Marshalls kicking in the doors and backing up and loading the proverbial turn-up truck. However, seizure is one of the more powerful tools in FDA’s compliance tool chest.
The concept of detention, employed by FDA, is not unlike the pain associated with the after school detention of this doctor’s wayward youth.
This is the 21 st Century and if a device manufacturer has not figured out that gauges need to be calibrated and traceable to a national standard, e.g. NIST, then the device manufacturer is probably in the wrong business.
When your friends from the agency stop by for that friendly cup of coffee and an inspection, they will ask to see DMRs and, eventually, review DHRs to verify finished medical devices are being properly manufactured.
Instead of attempting to rationalize why your current approach to identification and traceability is acceptable, just bite the bullet and script a high-level SOP.
You must have a Device Master Record, so just go ahead and create one; once the DMR has been assembled, do not forget to update it.
If your organization decides to pursue and RI program, jump into the deep end of the pool with both feet and do not be afraid of getting wet.
Good Document Practices continues to be problematic for device manufacturers and their suppliers.