May 14, 2018

Media Inquiries

  Stephanie Caccomo
  301-348-1956

“We’re taking steps to modernize our regulations concerning the classification and assignment of medical products, including combination products, to individual centers for review. We understand that regulatory uncertainty can stifle innovation as companies may avoid developing products. To promote the continued innovation of combination products, we want to make sure the process for classifying and assigning these products is clear and efficient,” said Thinh Nguyen, director of the FDA’s Office of Combination Products. “To further this effort, today we are proposing a rule that would update the regulations to bring greater clarity to their scope, streamline and clarify the appeals process for manufacturers, and align the regulations with more recent legislative and regulatory measures. This proposed rule, if finalized, would bring more transparency to the combination product regulatory process.”

Today, the FDA "published a proposed rule" to amend its regulations concerning the classification of products as biological products, devices, drugs or combination products and their assignment to agency components for premarket review and regulation. Combination products are products comprised of two or more different types of medical products (drug, device and/or biological product).

These regulations address the process for obtaining answers to important initial questions for medical product developers, including what type of medical product they are seeking to develop and market and which agency component will have the lead for premarket review and regulation. Providing a mechanism to address these questions when the answers may be unclear or in dispute enables developers to understand the regulatory expectations and processes that will apply, which can be important to product development planning.

This proposed rule, if finalized, will provide industry with greater transparency about the FDA’s classification and center assignment process for combination products and other medical products. For example, the proposed rule would align the regulations with more recent legislative and regulatory measures and remove out-of-date advisory content that does not accurately reflect current agency practices and policies. The FDA welcomes comments from stakeholders regarding this important step in bringing greater clarity and efficiency to combination product regulation.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.