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United States of America v. Regenerative Sciences, LLC, 741 F.3d 1314, was a decision in the United States Court of Appeals for the District of Columbia Circuit filed on February 4, 2014 concerning more than minimally manipulated cell therapies and whether they are considered part of medical practice or a drug, the latter subjecting it to regulation under the Food and Drug Administration (FDA). Regenerative Sciences LLC marketed a therapy procedure called Regenexx-C for the treatment of arthritis and orthopedic injury that involved extraction and culture of mesenchymal stem cells from the same patient which were later reinjected. In 2008, The FDA notified Regenerative Sciences LLC that the procedure may not be in compliance with their regulation using an Untitled Letter, which began a series of suits and counter suits, leading to the 2014 decision upholding the FDA’s regulation of more than minimally manipulated stem cell therapies.
A premarket tobacco application (PMTA) is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco product can be legally marketed in the United States. The first PMTA, and only to date, was approved by US FDA on November 10, 2015, when the FDA authorized the marketing of eight Swedish Match North America Inc. snus smokeless tobacco products.
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.
References
- ↑ "CFR Title 21". US FDA. Retrieved February 10, 2014.
- ↑ Food and Drug Administration (2008). "Subchapter A — General: Financial Disclosure by Clinical Investigators" . Retrieved 9 April 2009.
- ↑ Food and Drug Administration (2008). "Subchapter H — Medical Devices: Part 814 Premarket Approval of Medical Devices" . Retrieved 9 April 2009.
- ↑ Food and Drug Administration (2008). "Subchapter H — Medical Devices: Part 820 Quality System Regulation" . Retrieved 9 April 2009.
- ↑ "Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah". FDA.gov. United States Food and Drug Administration. Retrieved 11 May 2016.
