The US Food and Drug Administration (FDA) has 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.

“We’re taking steps to modernize our regulations concerning the classification and assignment of medical products, including combination products, to individual centers for review,” said Thinh Nguyen, Director of the FDA’s Office of Combination Products in a May 14, 2018 agency statement. “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.”

The 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. The agency says that 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.

The proposed rule, if finalized, is expected to provide industry with 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example, the proposed rule would align the regulations with more recent legislative and regulatory measures and remove out-of-date advisory content that does not accurately reflect current agency practices and policies.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 says it welcomes comments from stakeholders regarding these measures.

Source: FDA (Federal Register notice)