FDA / EU / Regulatory Updates
Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. To assist device manufacturers who are interested in seeking approval or clearance of OTC devices, the U.S. Food and Drug Administration (FDA) developed a new web page to address common questions about the FDA’s regulation of these devices.
OTC medical devices typically have the following characteristics:
- They can be used outside of healthcare settings.
- They are adequately labeled such that:
- The consumer (lay user) can self-diagnose their condition, self-select that the device is appropriate, self-treat, and self-manage the condition that the device is intended to treat or diagnose.
- The consumer (lay user) is able to understand how to use the device correctly (based on the labeling, including the instructions) without any help from a healthcare provider.
- The device has low potential for reasonably foreseeable misuse.
- The safety margin is such that the benefits of having an available OTC device outweigh the risks.
Examples:
- Self-Monitoring Blood Glucose Test Systems
- IVD home self-tests (for example, pregnancy)
- Laser-based hair removal and hair growth devices
Human factors (usability) testing can play an especially critical role in identifying the hazards associated with the use of a medical device by lay persons (not trained medical personnel).
Software devices and connected devices, including OTC devices, raise a number of unique considerations, including software validation, cybersecurity, and interoperability.
Example of OTC software device: Calculator, Drug Dose
New EU MDR (Medical Device Regulation) introduces an identification system, or UDI (Unique Device Identification), for medical devices approved for use in the EU. The purpose of this new requirement is to allow for clear and unambiguous identification of specific medical devices and facilitate their traceability on the market.
According to Article 27 of the MDR, the UDI comprises of a Device Identifier (“UDI-DI”), which is specific to a manufacturer and a device, and the Production Identifier (“UDI-PI”), which identifies the unit of device production.
The new MDCG Guidance describes several QMS areas to be considered for integration with UDI requirements:
- Design and development
- Product documentation and retention
- Production and process
- Serious incidents and field safety corrective actions (FSCA)
- Purchasing controls
- Documentation and records
- Enterprise resource planning
- UDI data provided to the Eudamed database
In addition, the software used in implementing the UDI system (e.g. UDI labelling of devices and packaging, machine to machine automatic upload of UDI data to EUDAMED) should remain in a validated state in accordance with relevant procedures.
Recalls
The Dose IQ Safety Software is a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications. Those medications are delivered into a person’s body in controlled amounts using the Spectrum IQ infusion pump.
A software defect may lead to mismatched drug information in drug libraries created using version 9.0.x of the computer-based software. If the software’s drug identifier does not match the drug information in the pump, the drugs may be improperly configured and cause serious adverse events including delay in therapy, under-infusion, or over-infusion of medication.
There have been 15 complaints, no injuries, and no deaths reported for this issue.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
