What is the 21st Century Cures Act

by Sarah Koehler | Mar 24, 2022 | Compliance, Consulting Group, FDA, QMS, Quality, Quality Systems, Regulatory, Standardization, Standards

21st Century Cures Act, FDA regulatory changes,

Since 2016, the 21^st Century Cures Act (Cures Act) has been implemented to expedite medical product development and share new advancements and innovations with patients who need efficient solutions as soon as possible.

Building on the Federal Drug Administration’s (FDA) continuous improvement to keep the patients in mind during the development of new drugs, biological products, and medical devices the Cures Act assists with the speed and modernization of clinical trials and testing. The use of clinical outcome assessments and first-hand evidence has increased the development and review of medical products.

The Cures Act assists in providing a new power for the FDAs the ability to increase the technical, scientific, and professional expertise and expedites new product development programs. Under this act, the FDA has been able to create multiple institutions to assist with the coordination activities with disease regions linking devices, drug biologics, and regulation of combination products. Through the Cures Act, the Breakthrough Device Program and Regenerative Medicine Advanced Therapy have been able to offer new and innovative devices and products across the country.

The FDA has been working to maximize the resources Congress has granted for the Cures Act. This Act was provided approximately $500 million over 9 years to cover the FDA expenses to officially implement the 21^st Century Cures Act. There has been a work plan in place to demonstrate how the FDA is using that funding which is subjected to annual allotments. The FDA’s final work plan for the 21^st Century Cures Act was submitted to Congress and signed in June of 2017.

If your company needs assistance with working your product through any of the novel pathways established by the 21^st Century Cures Act, EMMA International can assist. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.

[1] FDA (January 2020) 21^st Century Cures Act, Retrieved 3/21/2022 from https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.