Not to be condescending but I'm just going to list parts of the article where products and devices are mentioned If you read past the first paragraph, you will see that "devices and products" are what are mainly highlighted in this new RMAT designation... i barely even see where drugs are mentioned besides in the beginning... I think Endonovo's "product or device" whatever you want to call it, fits in very nicely with what is being mentioned in this article...
Today the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.
The framework – outlined in a suite of four guidance documents – builds upon the FDA's existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products.
As such, it has presented unique challenges to researchers, health care providers, and the FDA as we seek to provide a clear pathway for those developing new therapies in this promising field, while making sure that the FDA meets its obligation to ensure the safety and efficacy of the medical products that patients rely upon.
With the policy framework the FDA is announcing today, we're adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA's authorities and enforcement priorities.
As this field advances, the FDA has noted that there are a growing number of regenerative medicine products subject to FDA premarket authorization. These guidance documents will help explain how the FDA will provide a risk-based framework for its oversight. The policy framework defines how we intend to take action against unsafe products while facilitating continued innovation of promising technologies.
Going forward, the FDA will apply a risk-based approach to enforcement, taking into account how products are being administered as well as the diseases and conditions for which they are being used. This risk-based approach allows product manufacturers time to engage with the FDA, as to determine if they need to submit a marketing authorization application and, if so, submit their application to the FDA for approval.
The first draft guidance, which builds off the regenerative medicine provisions in the 21st Century Cures Act, addresses how the FDA intends to simplify and streamline its application of the regulatory requirements for devices used in the recovery, isolation, and delivery of regenerative medicine advanced therapies (RMATs), including combination products. The guidance specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.
The second draft guidance describes the expedited programs that may be available to sponsors of regenerative medicine therapies, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review, and Accelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation – including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, as well as gene therapies that lead to a durable modification of cells or tissues (including genetically modified cells).
"In addition to clarifying some of the more complex areas of the regulations, we have taken meaningful new steps to encourage and expedite the development of innovative therapies."
