Summary: S.2977 — 113th Congress (2013-2014)All Information (Except Text)

There is one summary for S.2977. Bill summaries are authored by CRS.

Shown Here:
Introduced in Senate (12/04/2014)

Medical Electronic Data Technology Enhancement for Consumers’ Health Act or the MEDTECH Act - Amends the Federal Food, Drug, and Cosmetic Act to exclude from regulation as a medical device:

  • administrative, operational, or financial records software used in health care settings;
  • products intended for health maintenance outside of medical treatment;
  • electronic patient records, excluding diagnostic image data, provided that related software is validated prior to marketing, consistent with the standards for devices;
  • software for clinical laboratory test reports; and
  • software that provides medical recommendations and the basis for those recommendations to health care professionals, with exceptions for products related to regulated devices.