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Medical Devices / Regulatory Affairs

FDA Urged to Clarify Quality Guidance for Combination Products

April 17, 2019
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A trade group representing manufacturers of combination drug-device products is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards.

In January, the agency issued a draft guidance that would allow CDER officials to “informally recognize” voluntary consensus standards related to pharmaceutical quality.  The Combination Products Coalition (CPC), a Washington, DC-based trade association, worries that the “relatively broad” wording may be confusing for companies that make combination products. It is asking the FDA to clarify the scope of the guidance and say how it will integrate with standards laid out by CDRH.

The coalition urged the FDA to “explicitly state in the draft guidance that the CDER program applies to the device constituents of combination products under CDER jurisdiction.”

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