FDA proposes streamlining combination product regulations

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the regulations to enhance consistency with the 21st Century Cures Act (the Cures Act) and other guidance that has been released since the regulations were last amended, and to reflect accurately agency and industry experience in addressing combination product designations.

Additional changes are proposed to specific procedures applicable to combination products, including clarification of the scope of product jurisdiction regulations and streamlining of the product classification appeals process. While clarification and alignment of the applicable regulations, policies, and current practices is helpful, the proposed rule downplays some of the opportunities for innovative change in the regulation of combination products suggested by Congress in the Cures Act by stating in a footnote that revision of Part 3 is "not necessary" because the agency's existing practices are already substantially in compliance with the Cures Act.

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