CPC Requests Extra 30 Days to Comment on FDA’s Proposed Framework for Regulating Software Intended for Use with Prescription Drugs

The CPC has been intently focused on the issue of how FDA will regulate software developed for use with drugs and believes additional time (until February 21, 2019) for commenting on FDA’s proposed framework is warranted given:

•  the timing of the commenting period (which falls across the holidays);
•  the length and complexity of the proposal;
•  the limited window for potential discussion with FDA before submitting comments; and
•  the fact that an extension is unlikely to harm the interested parties.