FDA's new regulatory paradigms for in vitro diagnostic devices
| Autor: | S.I. Gutman, M. Robinowitz |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Cancer Research
Transplantation Government business.industry United States Food and Drug Administration Immunology Internet privacy Cell Biology Bioinformatics In vitro diagnostic United States Oncology Equipment and Supplies Statutory law Device Approval Government Regulation Immunology and Allergy Humans Reagent Kits Diagnostic business health care economics and organizations Genetics (clinical) |
| Zdroj: | Cytotherapy. 1(4) |
| ISSN: | 1465-3249 |
| Popis: | This is a summary of the FDA’s response to new statutory requirements imposed by the US Congress through the FDA Modernization Act (FDAMA) of 1997. Congress intends to facilitate the development of new, safe and effective drugs and medical devices by requiring the FDA to accept the least burdensome route to market, consistent with no decrease in the level of reasonable safety and effectiveness. This will balance premarket review with appropriate postmarket surveillance and increase the premarket interaction of the FDA with the manufacturers of drugs and medical devices. Appendices describing the role of the Center for Devices and Radiologic Health of the FDA in the development cycle of medical devices, and the overall benefits and disadvantages of this regulation are given later. Websites are provided for access to the original documents from the FDA and through links to other government agencies and stake-holders in medical products. These can be viewed at: http://fda.gov (FDA as a whole), [FDA Center for Devices and Radiologic Health (CDRH)] http://fda.gov/cdrh. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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