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FDA's Drug Center Permits Some Combo Product Software To Be Submitted As DMFs

 
• By Derrick Gingery

New draft guidance from the US agency allows electronics or software that will be used across multiple combination products to be submitted as a Type V drug master file (DMF), potentially streamlining the assessment process.

Data synchronization of health book between smartwatch and smartphone in male hands
Sponsors have to explain in their applications why the device constituent part should be included in a DMF, and not an IND, NDA, ANDA or BLA

The US Food and Drug Administration moved to further streamline the combination product approval process by allowing some electronic or software constituent parts to be submitted as drug master files.

When the agency's Center for Drug Evaluation and Research (CDER) is leading the assessment of the application, sponsors now can use a Type V drug master file (DMF) to describe electronics or software "that is planned to be used as a platform," or in multiple CDER-led combination products, the FDA said in new 

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