A new guidance document released this week provides the US Food and Drug Administration's (FDA) recommendations for sponsors who choose to develop a type of combination product known as pen/jet injectors.
The injectors are composed of a medical device (the injector) and either a drug or biologic substance which is injected into the patient. In the case of jet injectors, this injection occurs at a high rate of speed, imitating a hypodermic needle in effect. Jet injectors are often used for large-scale vaccination programs, as they allow a quicker way to vaccinate people without the use of needles, which are costly and can spread infection.
However, the far more common variant is the pen injector-pre-filled syringes that allow patients to select the exact dose of a product they need to inject, allowing them a safer method of complying with their treatment regimen. Most also allow the user to simply press a button to inject the fluid into the body, further simplifying the process.
The devices, in addition to pen and jet injectors, also include piston syringes, needle-free injectors, mechanically operated injectors and injectors with computerized or electronic elements, and are broadly classified as Class II (moderate-risk) medical devices capable of using the premarket notification (510(k)) process. Some come pre-filled, while others are co-packaged with a particular drug product.
And, as with all combination products, they come with a unique set of regulatory hurdles to clear before being allowed to market. The most basic of questions is, simply: Who regulates this product, and how? FDA explains that most injectors are regulated by the Center for Devices and Radiological Health (CDRH), FDA's medical device regulatory center. However, if the drug itself is found to be the product's primary mechanism of action (PMOA), then the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) will have product jurisdiction, requiring a drug application instead of a 510(k) application.
FDA's guidance delves extensively into how sponsors should go about structuring their premarket submissions to meet regulatory requirements, starting with a description of the injector product, its intended indications for use, a description of how the product will be used and a description of the drug product intended to be used with the injector.
"If you are proposing your injector for use with an unapproved drug or biological product, or for use with an approved drug or biological product but using a new route, dose, rate or method of injection, the relevant Centers will identify the necessary data for the premarket review of the drug/biological product, and the appropriate type of submission(s) for the unapproved product(s) and the injector," FDA explained, adding that contacting the Office of Combination Products (OCP) is advisable in such cases.
The guidance also provides ample information about the design of the device, noting the general comparison points necessary to support a 510(k) application, as well as the supporting materials needed for a successful application (engineering drawings, photographs, dose setting information, information about graduation marks and fill lines, safety features and design elements).
Other considerations on materials, biocompatibility testing, shelf-life stability testing, environmental condition testing, functional testing, dose accuracy, injection assessment, and general human factors testing are all included in the guidance, which may be found here.
Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products