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FDA Establishes New Process for Preliminary Combination Product Classification

Posted 11 August 2016 | By Michael Mezher 

FDA Establishes New Process for Preliminary Combination Product Classification

Top officials at the US Food and Drug Administration (FDA) say the agency is developing a new, less formal, way for industry to request input on how combination products will be regulated.

Combination Products

Combination products are products that combine two or more different types of FDA-regulated products, including drugs, biologics and medical devices. However, when it comes to reviewing such products, FDA makes a determination as to how the product will be classified and which of its offices will carry out the premarket review, based on the product's primary mode of action.

For example, a skin patch that contains a drug to treat Parkinson's symptoms would be regulated as a drug, rather than a medical device, as the product's primary mode of action is through its drug component. This means that such a product would require a sponsor to file a new drug application (NDA), with the product review being carried out under the Center for Drug Evaluation and Research (CDER).

Because this determination can have a significant impact on a product's development, sponsors can request a designation from FDA early by submitting a request for designation (RFD) to the Office of Combination Products (OCP) in cases where it's unclear how their product should be classified, or if they anticipate a dispute over its classification with FDA.

Earlier this month, FDA announced a new pilot project linked to its intercenter consult request process (ICCR). To improve combo product submission review at FDA, the agency is stressing the need for closer intercenter collaboration and communication and is planning to test certain aspects of those collaborations in the pilot, with the goal of achieving implementation across all FDA offices by the end of Q2 2017.

Pre-RFD Process

Now, FDA says it plans to institute a "Pre-RFD" process to allow sponsors to get product classification about a product in a preliminary manner, while requiring less information than a formal RFD.

"The Pre-RFD process can be used at any point during medical product development. It may be preferable to the more formal RFD process when a sponsor would like to engage FDA using a more interactive approach—a course that may be especially helpful when a medical product is at an early stage in its development, or when a sponsor is contemplating whether to develop a specific product, or what configuration of that product to pursue," write OCP Director Thinh Nguyen and Rachel Sherman, FDA's associate deputy commissioner for medical products and tobacco.

For instance, through the Pre-RFD process, a sponsor would not have to provide a recommendation for classification and assignment with evidence to support their recommendation, such as bench studies or clinical trials.

Pre-RFD Flow Chart

FDA plans to give sponsors feedback on product classification and which center will assess a product through the Pre-RFD program in the same 60-day window as for formal RFDs.

Nguyen and Sherman also say that FDA is working to issue draft guidance for sponsors to further detail how to use the Pre-RFD process, and plans to publish a list of product classifications for industry to reference.

"We believe this list will offer additional transparency and clarity to sponsors that will ultimately foster innovation and promote better health for patients," they write.

FDA Voice


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