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The 21st Century Cures Act or Cures Act, is a USA law that was enacted on December 13, 2016. The Act consists of 18 titles that are further divided into various sections. It was designed to accelerate the medical product development, usher new innovations and advances for faster availability to patients with improved efficiency.

For meeting these objectives, various measures like expediting the approval process of seemingly beneficial therapies, and waiving the informed consent were proposed. Also, there is a proposal to deregulate seemingly low-risk medical devices like Fitbit and certain software which are regulated by the USFDA. With advancing technology, this is a clear shift by the FDA towards creating newer guidelines towards regulating novel therapies like Artificial Intelligence medical devices to which the conventional regulations seem obsolete.

It also proposes providing authority to the FDA to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs, including:

  • The Regenerative Medicine Advanced Therapy, or RMAT; offers a new expedited option for certain eligible biologics products.
  • The Breakthrough Devices program; designed to speed the review of certain innovative medical devices.

The Act also proposes funding for the treatment of diseases concerned with mental health, rehabilitation and therapy of the people affected by drug abuse. The above is a small gist of the entire Act which consists of multiple proposals and the funding involved. Here, you can access the full Act.

Current Scenario

Though the Act was enacted at the end of 2016, it has yet to see the light of the day. The shift in the regime seems to be an impediment in making the Act practically possible, although, the FDA has been continuously trying to reassure that there will be no political ramifications due to the change in the regime. But, the actions of the government seem to be exactly opposite to that. With significant funds being slashed for healthcare by the Trump administration, the Act seems all but watered down. What remains to be seen is that if the USFDA can successfully implement this Act and lay a strong foundation for Novel therapies entering the market.

It is important to understand that this Act is yet to come into picture, therefore, it is necessary to plan the development of your medical device accordingly. To know more about the 21st Century Act and to for any assistance for medical device registrations in the US, contact our experts at sales@freyrsolutions.com.