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The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
An investigational device exemption (IDE) allows an investigational device to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
INSIGHTEC Ltd., is a privately held medical device company that sells MR guided Focused Ultrasound equipment. The technology can destroy deep tissue in the body without the need for incisions.
Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. As of 2016, the only established therapy using stem cells is hematopoietic stem cell transplantation. This usually takes the form of a bone-marrow transplantation, but the cells can also be derived from umbilical cord blood. Research is underway to develop various sources for stem cells as well as to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes and heart disease.
Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to its name, the company then branched out into the study of both cytokine and tyrosine kinase receptors, which gave rise to their first product, which is a VEGF-trap.
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Spray-on skin is a skin culturing treatment for burn, or other skin damage victims. It involves taking small samples of the patient's skin and spraying them on the wound.
Artificial disc replacement (ADR), or total disc replacement (TDR), is a type of arthroplasty. It is a surgical procedure in which degenerated intervertebral discs in the spinal column are replaced with artificial disc implants in the lumbar (lower) or cervical (upper) spine. The procedure is used to treat chronic, severe low back pain and cervical pain resulting from degenerative disc disease. Disc replacement is also an alternative intervention for symptomatic disc herniation with associated arm and hand, or leg symptoms.
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.
Artificial skin is a collagen scaffold that induces regeneration of skin in mammals such as humans. The term was used in the late 1970s and early 1980s to describe a new treatment for massive burns. It was later discovered that treatment of deep skin wounds in adult animals and humans with this scaffold induces regeneration of the dermis. It has been developed commercially under the name Integra and is used in massively burned patients, during plastic surgery of the skin, and in treatment of chronic skin wounds.
The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century. The main focus of this is the acknowledgment in the advancement of technological, trade, and public health complexities.
The dermal equivalent, also known as dermal replacement or neodermis, is an in vitro model of the dermal layer of skin. There is no specific way of forming a dermal equivalent, however the first dermal equivalent was constructed by seeding dermal fibroblasts into a collagen gel. This gel may then be allowed to contract as a model of wound contraction. This collagen gel contraction assay may be used to screen for treatments which promote or inhibit contraction and thus affect the development of a scar. Other cell types may be incorporated into the dermal equivalent to increase the complexity of the model. For example, keratinocytes may be seeded on the surface to create a skin equivalent, or macrophages may be incorporated to model the inflammatory phase of wound healing.
The Mynx Vascular Closure Device is an extravascular vascular closure device (VCD) whose deployment system is designed to minimize the discomfort commonly associated with closing the small hole in the artery following catheterization procedure. The device is manufactured by AccessClosure, Inc., a medical device company located in Mountain View, California.
Fiona Melanie Wood is an English-born Australian plastic surgeon working in Perth, Western Australia. She is the director of the Royal Perth Hospital burns unit and the Western Australia Burns Service. In addition, Wood is also a clinical professor with the School of Paediatrics and Child Health at the University of Western Australia and director of the Fiona Wood Foundation.
The MERCI Retriever is a medical device designed to treat Ischemic Strokes. The name is an acronym for Mechanical Embolus Removal in Cerebral Ischemia. Designed by University of California, Los Angeles in 2001, MERCI was the first device approved in the U.S. to remove blood clots in patients who had acute brain ischemia.
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.
Bioelectromagnetic medicine deals with the phenomenon of resonance signaling and discusses how specific frequencies modulate cellular function to restore or maintain health. Such electromagnetic (EM) signals are then called "medical information" that is used in health informatics.
Integra LifeSciences is a global medical device manufacturing company headquartered in Princeton, New Jersey. Founded in 1989, the company manufactures products for skin regeneration, neurosurgery, reconstructive and general surgery. Integra artificial skin became the first commercially reproducible skin tissue used to treat severe burns and other skin wounds.
References
- ↑ Bland, Eric (November 23, 2009). "Spray-on skin speeds up healing burns". ABC Science. Australian Broadcasting Company. Retrieved December 26, 2015.
- ↑ 2015 Concise Annual Report (PDF). Avita Medical. 2015. Archived from the original (PDF) on 2016-01-07. Retrieved 2015-12-28.
- ↑ House, Douglas W. (December 24, 2015). "Avita Medical sells respiratory business to MDI for $2.64M". Seeking Alpha. Retrieved December 28, 2015.
- ↑ "OTC Markets | Official site of OTCQX, OTCQB and Pink Markets". www.otcmarkets.com. Retrieved 2019-03-21.
- ↑ "AVITA Medical Announces FDA Approval of Expansion of RECELL Compassionate Use Program in Life Threatening Injuries". businesswire. 11 February 2018. Retrieved 11 March 2021.
- ↑ "Avita taps investors for $17m". Business News. 2017-10-11. Retrieved 2017-12-20.
- ↑ "Avita Medical Announces Submission Of U.S. FDA Premarket Approval (PMA) Application For The Recell Device For Treatment Of Burn Injuries". BioSpace. 28 September 2017. Retrieved 11 March 2021.
- ↑ "Archived copy" (PDF). Archived from the original (PDF) on 2018-02-28. Retrieved 2018-02-27.
{{cite web}}: CS1 maint: archived copy as title (link) - ↑ "September 20, 2018 Approval Order - RECELL Autologous Cell Harvesting Device" (PDF). U.S. Food and Drug Administration. 2018-09-20.
- ↑ Greenblat, Eli (May 27, 2009). "Avita boosted by US affirmation". The Age.
- ↑ "Valley woman continues recovery from rare flesh-eating bacteria infection".
