Policy Positions & Comments

April 3, 2012

Letter to FDA re re-propose mobile medical application guidance

The Coalition has submitted a letter to FDA again requesting that the agency re-propose the guidance on mobile medical applications. This joint letter is a follow-on to the January letter and is supported by a number of organizations that submitted comments on the original draft guidance.

January 23, 2012

Letter to FDA re re-propose draft guidance

On January 20, 2012, the MRC sent a letter to the FDA requesting that the Agency re-propose the draft guidance, allowing the public a reasonable opportunity to comment before the issuance of a final document.

October 20, 2011

Proposed guidance document

The mHealth Regulatory Coalition is pleased to announce that, after more than a year’s worth of work, we submitted our proposed guidance document on October 19, 2011 as comments to the FDA’s draft guidance on mobile medical apps. The full comments on the Agency’s draft guidance can be found here.

September 30, 2011

Pre-submission draft proposed guidance document

After nearly nine months of development, the Coalition is releasing a pre-submission draft of its proposed guidance document. This draft combines the three documents released earlier this year and incorporates public comments from a variety of stakeholders.

June 27, 2011

Framework on complex issues associated with software in an mHealth ecosystem

The third and final portion of our proposed guidance document is now available for comment. We’ve focused this part on the complex issues associated with software in an mHealth ecosystem.

May 10, 2011

Accessory Framework

We’re moving along in our guidance development process. The second part of the proposed guidance document establishes a framework for addressing the regulation of accessories in an mHealth product.

April 25, 2011

Intended Use Claims Framework

The first of a three-part guidance document that the mHealth Regulatory Coalition plans to submit to FDA, this document is our initial attempt to develop a framework for determining what intended use claims would trigger regulation of an mHealth product by the agency.

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