Prescription vs OTC Device Labelling
Prescription (Rx) devices
A device is a prescription device if it bears the statement restricting sale to the order of a licensed practitioner — typically because:
- It is a device for use in conditions that are not amenable to self-diagnosis or treatment by a layperson
- Collateral measures necessary to its use are available only through licensed practitioners
Prescription device status may be:
- Required by the 510(k) clearance or PMA approval conditions
- Established by the manufacturer through labelling (with appropriate regulatory basis)
- Mandated by the applicable product classification regulation in 21 CFR Parts 862–892
Over-the-Counter (OTC) devices
OTC devices may be sold and used by consumers without a practitioner's order. OTC labelling must:
- Comply with adequate directions for use requirements
- Include appropriate warnings and precautions
- Meet any applicable OTC labelling format requirements
- For IVDs: include instructions comprehensible to a lay user
Home-use vs professional-use device distinction
Many device types exist in both professional-use and home/consumer versions. A glucose meter used by a diabetic patient at home is an OTC IVD; the same technology in a hospital laboratory is a professional-use device. These may have different 510(k) clearances and product codes based on intended use.