FDA Mobile Health Policy Proposal Draws Fire From Far And Wide
This article was originally published in The Pink Sheet Daily
A draft guidance meant to clarify FDA's regulatory policies surrounding mobile medical applications has raised as many questions as it tried to answer.
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Pfizer and Sanofi representatives discuss how pharmaceutical firms can best leverage mobile platforms to reach consumers. Elements to consider include ensuring a mobile website makes a good first impression, delivering a message that is simple and on-point, integrating the mobile platform strategy with the brand strategy and considering how best to use tools like text messaging and apps.
Pending FDA guidance on mobile medical applications will be of most value in reaching out to those software developers who have not yet worked within the medical device industry, CDRH policy advisor Bakul Patel emphasized last week.
The medical device and software industries voiced support last week for a July 19 FDA draft guidance that helps clarify the types of mobile software applications that would face FDA regulation.