The U.S. Food and Drug Administration (FDA) has released a guidance document to better clarify the regulatory processes for molecular diagnostic devices, especially those that can be used for multiple unrelated assays. This includes both approved or cleared functions — such as testing for a certain virus or bacterial infection — and functions that do not require approval or clearance, like basic scientific research.
A premarket submission for this type of molecular diagnostic instrument should meet certain regulatory criteria. First, sufficient measures should be in place to ensure that the functions for which approval and clearance are not necessary do not interfere with the approved/cleared functions. Second, the end-user must not be confused regarding the functions of the device.
The FDA provides five examples of measures that could meet these requirements:
- Instrument and software design controls
- Result reports distinguishing between the approved/cleared functions and the functions that do not require clearance or approval
- Labeling that distinguishes between the functions
- Instrument validation procedures that users can follow to ensure that one function does not interfere with another, subsequent function
- A risk mitigation plan demonstrating any potential risks
All device-related adverse events must also be reported to the FDA, regardless of whether the event was associated with an approved/cleared function or with a function that does not require clearance or approval.