Archive for the ‘21st Century Cures Act’ Category

Skin Regeneration Therapy One of First Tissue Engineering Products Evaluated by FDA

Reporter: Irina Robu, PhD

Under the provisions of 21st Century Cures Act the U.S. Food and Drug Administration approved StrataGraft regenerative skin tissue as the first product designated as a Regenerative Medicine Advanced Therapy (RMAT) produced by Mallinckrodt Pharmaceuticals. StrataGraft is shaped using unmodified NIKS cells grown under standard operating procedures since the continuous NIKS skin cell line has been thoroughly characterized. StrataGraft products are virus-free, non-tumorigenic, and offer batch-to-batch genetic consistency.

Passed in 2016, the 21st Century act allows FDA to grant accelerated review approval to products which meet an RMAT designation. The RMAT designation includes debates of whether priority review and/or accelerated approval would be suitable based on intermediate endpoints that would be reasonably likely to predict long-term clinical benefit.

The designation includes products

  • defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products;
  • intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
  • preliminary clinical evidence indicates the drug has the potential to address unmet medical needs for such disease or condition.

According to Steven Romano, M.D., Chief Scientific Officer and Executive Vice President, Mallinckrodt “We are very pleased the FDA has determined StrataGraft meets the criteria for RMAT designation, as this offers the possibility of priority review and/or accelerated approval. The company tissue-based therapy is under evaluation in a Phase 3 trial to assess its efficacy and safety in the advancement of autologous skin regeneration of complex skin defects due to thermal burns that contain intact dermal elements.



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21st Century Cures Act reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries – Medical Device Overview: Major FDA Reform Bill Becomes Law

Reporter: Aviva Lev-Ari, PhD, RN



  • The 21st Century Cures Act seeks to expedite development of, and provide priority review for, “breakthrough” devices
  • The act requires FDA to provide training on the meaning and implementation of the least burdensome review standard, and requires an audit of the results
  • The act expressly excludes certain categories of medical software from FDA regulation

Major provisions of the act related to medical device regulation found in Subtitle F are listed, below.


President Obama recently signed the 996-page 21st Century Cures Act to implement a variety of reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries.

This alert summarizes the major provisions of the act related to medical device regulation found in Subtitle F.

Read more: http://www.btlaw.com/Food-Drug-and-Device-Law-Alert—Major-FDA-Reform-Bill-Becomes-Law-Medical-Device-Overview-12-13-2016/


Section 3051 – Breakthrough Devices

Section 3052 – Humanitarian Device Exemption (HDE)

Section 3053 – Recognition of Standards

Section 3054 – Certain Class 1 and Class II Devices

Section 3055 – Classification Panels

Section 3056 – Institutional Review Board Flexibility

Section 3057 – CLIA Waiver Improvements

Section 3058 – Least Burdensome Device Review

Section 3059 – Cleaning Instructions and Validation Data Requirement

Section 3060 – Clarifying Medical Software Regulation


A copy of the act can be found here.



For more information, please contact the Barnes & Thornburg LLP attorney with whom you work or one of the following attorneys in the firm’s Food, Drug & Device Group: Lynn Tyler at (317) 231-7392 or lynn.tyler@btlaw.com; Beth Davis at (404) 264-4025 or beth.davis@btlaw.com; or Alicia Raines Barr at (317) 231-7398 or alicia.rainesbarr@btlaw.com.

Visit us online at www.btlaw.com/food-drug-and-device-law-practices.





Other related articles published in this Open Access Online Scientific Journal include the following:

Medical Devices




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