Dive Brief:
- FDA Tuesday laid out how it plans to determine which type of application — drug, device or biologic — is appropriate for new combination products looking for marketing authorization in a new draft guidance.
- Possible submission types range from a new drug application to a 510(k), depending on the product. The agency notes "a single application is generally appropriate for combination products," and that cross-center collaboration will occur between its drug, device and/or biologic units.
- Commissioner Scott Gottlieb said FDA will be developing additional guidances outlining specific premarket considerations for combo products in the future.
Dive Insight:
Combination products, where a single product has components from two or more regulated areas or separate products are co-packaged, are often the subject of debate between sponsors and FDA.
At question is often which FDA center has primary jurisdiction over premarket review and regulation for a combo product.
The new draft guide lays out a high-level overview of the process the agency plans to use to assign products to FDA’s Center for Drug Evaluation and Research, Center for Devices and Radiological Health or Center for Biologics Evaluation and Research.
"Among other steps, we're clarifying what pathways to approval are available depending on whether a combination product is drug-led, biologic-led or device-led," Gottlieb said in a statement. "We're seeing innovations that hold out great promise, but they're increasingly blurring the lines across our medical product centers."
Gottlieb highlighted an example of a digital pill that combines a medicine that sends data to a wearable patch when it is ingested, which then relays the information to a mobile application.
"Because combination products often combine a drug or biologic with a device, these products can sometimes be more complex to develop — and it can be less clear to innovators on how to best engage the regulatory process to advance these innovations," Gottlieb said.
According to the draft guide, FDA will assign a product to a center based on its "primary mode of action." Companies can submit a request for designation if they want a binding classification, or a pre-RFD for initial informal feedback on the assignment of a product.
The agency noted that additional safety data may be needed for combo products that may not be required were a component a stand-alone product.
"Examples of this may include an anti-inflammatory drug on a cardiac lead to reduce inflammation at the implantation site or an anti-coagulant bound to the inner lumen of a catheter to prevent clot formation within the catheter thereby maintaining catheter patency," the draft guide states.
Five examples of theoretical product classifications are included in the draft guide to help address questions FDA that often come up for device-led combination products.
AdvaMed and PhRMA both told MedTech Dive they are still reviewing the draft guidance. PhRMA spokesperson Andrew Powaleny said the trade lobby "appreciated the agency putting out this draft guidance."
The new draft guide comes in response to a requirement in the 21st Century Cures Act. Under the law, FDA must finalize the guidance within 60 days of the comment period closing on May 7.
