MEDTECH Act

Summary

Medical Electronic Data Technology Enhancement for Consumers’ Health Act or the MEDTECH Act This bill amends the Federal Food, Drug, and Cosmetic Act to exclude from regulation by the Food and Drug Administration (FDA) as a medical device: administrative, operational, or financial records software used in health care settings; software for maintaining or encouraging a healthy lifestyle unrelated to medical treatment; electronic patient records, excluding software for interpreting or analyzing medical image data; software for clinical laboratory testing, excluding software for interpreting or analyzing test data; and software that provides medical recommendations and the basis for those recommendations to health care professionals, excluding software for acquiring, processing, or analyzing medical images or signals. The FDA may assess a software function excluded from regulation above when determining the safety and effectiveness of a medical device with multiple functions. The FDA must classify a medical device accessory based on its intended function, not based on the classification of the medical device with which it is used.

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 4 April 2016

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• Reported to Senate (PDF)

  Reported to Senate · EN · 4 April 2016

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• Reported to Senate with amendment(s)

  summary · EN · 4 April 2016

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• Introduced in Senate (text)

  Introduced in Senate · EN · 27 April 2015

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 27 April 2015

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• Introduced in Senate

  summary · EN · 27 April 2015

  Open at official source

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