An Analysis of 21st Century Cures Act

author

By: Satish Tiwari --

28 September, 2015

An Analysis of 21st Century Cures Act
ARTICLE

In month of July 2015, US congress approved of Cures act which aims at facilitating medical sector. This article is aimed at analyzing implications and concerns of this act in conjuncture with other acts such as UID. What does 21st Century Cures Act has for Medical Devices Sector

  1. Promoting innovations

Breakthrough Medical Devices: Cures act aims at expediting innovation in this sector by promoting medical devices which can be categorised as "breakthrough technologies".

  • An essential characteristic of these devices should be that they should be able to improve patient's quality of life via:
  • Treating conditions where no approved alternative exists
  • Offer significant advantage over alternative technologies present
  • Have potential to reduce/eliminate need for hospitalization

 

  1. Software Definition

This act tries to differentiate between "Medical Software" and Health Software" wherein FDA can regulate the former.

  1. Medical Device Supply Chain Security

This act aims at providing more clarifications regarding entities involved in sale and purchase of medical devices and taking measures to alert FDA to any counterfeit, misbranded or nonconforming devices in their possession.   Author: Satish Tiwari




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