Policy Positions & Comments

October 11, 2012

Unique Device Identification System

The Coalition sent a letter to the FDA commenting on the proposed rule regarding the Unique Device Identification (“UDI”) System. The Coalition urged FDA to adopt rules that would not stifle innovation in mHealth technology.

May 17, 2012

Letter to Senators Harkin and Enzi re delay of guidance

This week, Senators Bennet and Hatch proposed an amendment to the Senate’s proposed Food and Drug Administration Safety and Innovation Act that effectively would establish an 18-month moratorium on the publication of FDA’s final guidance on mobile medical applications. In response, MRC has sent a letter to Senators Harkin and Enzi (the Chairman and ranking minority member of the Committee on Health, Education, Labor and Pensions, respectively) expressing the Coalition’s opposition to a moratorium and requesting that the Senators oppose any proposal that would delay publication of the guidance.

April 27, 2012

Comments on 510(k) Draft Guidance

Because the 510(k) Program plays an important role in the regulation of mHealth technologies, the Coalition filed comments on the FDA’s draft guidance on April 26, 2012. Although the Agency’s draft guidance is a significant step toward clarifying the 510(k) Program, there are a number of areas that need clarification to produce a clear, predictable, and narrowly-tailored regulatory framework that promotes patient safety and innovation in mHealth.

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