- Combined functions
- Instruments that serve as a component of an FDA-cleared or approved IVD system but can also be configured by the user for other test purposes, such as basic research.
- Approved/cleared
- Refers to instruments and functions requiring approval through the PMA process or clearance through the 510(k) process.
- Refers to both PMA approval and 510(k) approval.
- Approval/clearance is not required
- Refers to instruments or functions that do not need to be approved or cleared by the FDA, such as those intended solely for use for basic research.
- Should
- Means something is suggested or recommended, but not required.
- Intended use
- "refers to the 'objective intent' of those responsible for labeling the product. Intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article" (DN1723§II)
- CFR
- Code of Federal Regulations. A common citation you'll see. It is the "codification of the general and permanent rules" published by the government. You can browse an online version at the eCFR.gov website.
- IVDs
- in vitro diagnostic devices.
- RUO and IUO
- Research Use Only, Investigational Use Only
- IDE
- Investigational Device Exemption (see 21 CFR part 812)
It is important to note that the FDA's guidance documents do not establish and legally enforceable rules. "Unless specific regulatory or statutory requirements are cited," they are only guidelines.