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February 27, 2014

Proposed Legislation to Remove FDA Oversight of Medical Software Would Put Patients at Serious Risk

Alliance of Healthcare Providers, Device and Software Makers Says Congress Shouldn’t Short-Circuit FDA Progress in Parsing High Risk, Low Risk Apps

WASHINGTON — Legislation that would remove a wide range of mobile healthcare applications and other medical software from federal oversight would pose serious, potentially life-threatening risks to patients and consumers. Rather than pre-empting the ongoing Food and Drug Administration (FDA) effort to identify low risk apps that shouldn’t require FDA review, Congressional staff should participate in the FDA process, holding the agency accountable for moving quickly and achieving the right balance.

For the full release, click here Proposed Legislation to Remove FDA Oversight of Medical Software Would Put Patients at Serious Risk.


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