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14. 05.2018

FDA seeks to bring clarity to combination product regulation

The FDA proposes a rule that would amend regulations regarding the classification of products as biological products, devices, drugs or combination products.

The agency said it hopes to modernize the regulations that surround the classification and assignment of medical products to individual centers for review – including drug-device combination products.

Specifically, the FDA wants to update the process designed to help medical product developers obtain answers to the questions that crop up during their early interactions with the agency. When companies engage with the regulatory process, some of the first obstacles they encounter relate to classification: is the product they’re developing a device? A drug? Both?

The FDA said it is aiming to provide the industry with more transparency about its classification and center assignment process for combination products. For example, the group wants to align regulations with more recent legislative measures, removing out-of-date advisory content.

“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,” Thinh Nguyen, director of the FDA’s office of combination products, said in prepared remarks.

The FDA’s proposed rule is now open for comment from stakeholders.

“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,” Nguyen said.

Source: Drug Delivery Business