The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the product lifecycle of infusion pumps. The guidance addresses matters related to the device description to be provided by the party interested in marketing its infusion pump in the US.
It is important to mention that due to its legal nature, the document does not establish any rules or requirements the parties involved shall follow but provides additional clarifications and recommendations to be considered. The Agency states that an alternative approach could be applied, provided it complies with the relevant regulatory requirements and has been approved by the authority in advance. The document also contains references to other guidance documents issued by the FDA and dedicated to certain specific matters.
According to the document, a 510(k) submission related to an infusion pump should contain a reference to applicable regulation and also a product code that applies to the device. In order to demonstrate conformity to the regulatory requirements, the applicant may also provide a comparison to a similar medical device already placed on the market (predicate). Such a comparison should be accompanied by data related to the predicate to which an applicant refers. The authority encourages applicants to provide side-by-side comparisons. Apart from the general information about the medical device required in accordance with 21 CFR 807.87, an applicant shall provide the following:
- Detailed indications for the use of the device covering such aspects as the intended use environment, the routes of administration, the population for which the device is intended to be used, and also information about any specific uses.
- Engineering documents describing the device’s design development process, including both input and output. As stated by the authority, this could include the documents describing the core components of the device.
- A detailed description of the device itself, as well as any accessories thereto. According to the guidance, such description should cover:
- The infusion delivery mechanism;
- The bolus mechanism;
- The drug reservoir;
- Pump tubing and connectors (built-in or external to the pump);
- A user-interface, consisting of the programming unit, display unit, audio and tactile notification units;
- Power supply;
- Pump battery and circuitry to charge and monitor the battery; and
- A communication interface, including network components and interfaces to other devices and systems.
- Description of the principle of operations of the device outlining the way the device achieves its intended purpose specified by the manufacturer.
- Should the infusion pump in question be initially intended to be used together with another medical device, information about such device should also be provided.
- References to the particular medicines or biologics the infusion pump is intended to administer. Such products should be allowed for marketing and use in the US.
- Should the infusion pump be intended to be used in an environment other than a clinical setting (e.g., in transport), the manufacturer shall also provide a detailed description of the corresponding device design features.
- Should the infusion pump be initially intended to be used by laypersons having no special knowledge or qualification, the manufacturer shall describe the measures implemented in order to mitigate the risks associated with such use.
- The indication of whether the device could be controlled remotely, together with the description of the appropriate safety measures implemented in order to prevent interruptions or unauthorised access.
- Should the infusion pump subject to review incorporate any wireless technologies, the appropriate information should be provided by the manufacturer as well. This information should cover wireless security measures implemented by the manufacturer.
- Should the infusion pump contain the software incorporated therein, the information to be provided by the manufacturer shall also contain the details about such software, namely:
- A drug library or other dose error reduction mechanism;
- A real time clock (RTC);
- On-board memory;
- Pump log;
- Alarm handler; and
- Watchdog timer.
- A detailed description of all communications the device will have with other medical devices when used in a clinical setting.
- Information about the user interface of the device, such as keypads, control menus, data entry screens, displays, indicator lights, alarms, auditory and tactile feedback, infusion sets, cassettes, free-flow prevention mechanisms, tubing, latches, doors or other components or accessories of the physical pump that may be manipulated.
- Details about how the infusion pump will be marketed (in respect of the condition it will be supplied in, and also the intended use).
As mentioned, in order to demonstrate that the new infusion pump complies with any and all applicable regulatory requirements, an interested party (e.g., a medical device manufacturer) may refer to an existing medical device already placed on the market and compare it to the new one. In such a way, an applicant will demonstrate that the safety and performance characteristics of a new device are similar to those of the predicate. This approach significantly reduces the regulatory burden for medical device manufacturers, as well as the time necessary to complete the regulatory procedures to be performed in order to place a new medical device on the US market. According to the present FDA guidance, such a comparison to a similar device should be provided in the form of a table containing the following details:
- The indications for use for each device, including the patient population for which the devices are intended (i.e., neonate, infant, pediatric, adult) and the intended use environment.
- The specifications for the devices, including but not limited to, flow accuracy specifications, time to occlusion alarm, dimensions, weight, ingress protection, power, and units of delivery.
- The technological features of the devices.
The Agency additionally emphasizes that the medical device manufacturer shall provide detailed information on differences between the technologies used for the devices in question and describe the way it impacts the safety and effectiveness.
In summary, the present FDA guidance provides additional clarifications regarding the scope of information about infusion pumps to be provided by medical device manufacturers applying for marketing approval for the devices they are going to place on the US market. The document highlights the most important aspects to be considered, including the specific points to be addressed depending on the design, functions, intended use, or intended use environment of an infusion pump and also clarifies the way the manufacturer may make references to similar medical devices already placed on the market and provide comparisons in order to demonstrate compliance of the new product with the applicable regulatory requirements in terms of safety and performance.
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