| Autor: |
Samuels-Reid JH; Center for Devices & Radiological Health, US Food & Drug Administration, 10903 New Hampshire Ave WO 66 - 2608, Silver Spring, MD, 20993 USA., Blake ED |
| Jazyk: |
angličtina |
| Zdroj: |
Expert review of medical devices [Expert Rev Med Devices] 2014 Mar; Vol. 11 (2), pp. 169-74. Date of Electronic Publication: 2014 Jan 06. |
| DOI: |
10.1586/17434440.2014.864234 |
| Abstrakt: |
There are many barriers to the availability of medical devices intended for the pediatric population causing healthcare providers to use creative measures to address pediatric unmet device needs. The USA has taken significant legislative measures to spur medical device development and address the unmet needs in all pediatric subpopulations. For example, the Medical Device User Fee and Modernization Act of 2002 amended the Federal Food Drug and Cosmetic Act by adding new provisions intended to promote the development of safe and effective pediatric devices, and to protect the pediatric population during clinical trials. In 2004, the Medical Devices Technical Corrections Act was added to address potential difficulties in bringing pediatric devices to the market. Further, the Pediatric Medical Device Safety and Improvement Act of 2007 and the Food and Drug Administration Amendments Act of 2007 provided the FDA significant new responsibilities and authorities regarding pediatric use. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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