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Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say

Top FDA officials, including CDRH Director Jeffrey Shuren and FDA Deputy Commissioner Robert Califf, are sending strong signals that the designation and review processes for combination products are due for a significant reassessment. That should be a priority topic of upcoming user fee negotiations with industry, they say.

Top officials at FDA are signaling that the combination products review process is ripe for reform and the 2017 user fee reauthorizations will offer a good opportunity to make needed changes.

Companies and FDA each have frustrations with mismatches between drug and device regulations and with communication challenges between the product centers that lead to inefficiencies.

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