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FDA Wants Mobile App Guidance To Connect With Device-Reg-Naïve Developers

This article was originally published in The Gray Sheet

Executive Summary

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.

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A draft guidance meant to clarify FDA’s regulatory policies surrounding mobile medical applications has raised as many questions as it tried to answer.

FDA Mobile Health Policy Proposal Draws Fire From Far And Wide

A draft guidance meant to clarify FDA's regulatory policies surrounding mobile medical applications has raised as many questions as it tried to answer.

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