Gao Pediatric Medical Devices

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Pediatric Medical Devices: Provisions Support …

https://www.gao.gov/products/gao-12-225

What GAO Found. Certain characteristics unique to pediatric populations—including physiological differences from adult patients and challenges with recruiting pediatric participants for clinical trials—are barriers to developing …

GAO-12-225, Pediatric Medical Devices: Provisions …

https://www.gao.gov/pdf/product/587164

To describe the barriers to developing pediatric medical devices, we interviewed officials and reviewed documents from key pediatric medical device stakeholders, including …

GAO-12-225 Highlights, Pediatric Medical Devices: …

https://www.gao.gov/pdf/product/587163

Finally, FDAAA required GAO to report on pediatric device development. This report (1) describes barriers to developing pediatric devices, (2) describes how pediatric …

Federal Rules: MEDICAL DEVICES; PEDIATRIC USES …

https://www.gao.gov/fedrules/162697

medical devices; pediatric uses of devices; requirements for submission of information on pediatric subpopulations that suffer from a disease or condition that a device is …

Federal Rules: MEDICAL DEVICES; PEDIATRIC USES …

https://www.gao.gov/fedrules/161179

MEDICAL DEVICES; PEDIATRIC USES OF DEVICES; REQUIREMENT FOR SUBMISSION OF INFORMATION ON PEDIATRIC SUBPOPULATIONS THAT SUFFER …

GAO-13-438, National Preparedness: Efforts to …

https://www.gao.gov/pdf/product/654264

HHS addresses dispensing of pediatric medical countermeasures in more than half of its 12 response plans and in its guidance, and seven state and seven local government …

National Preparedness: Efforts to Address the Medical …

https://www.gao.gov/products/gao-13-438

According to the Department of Health and Human Services (HHS), about 60 percent of the chemical, biological, radiological, and nuclear (CBRN) medical …

GAO Reports on Approval of Pediatric Medical Devices

https://www.thefdalawblog.com/2011/12/gao-reports-on-approval-of-pediatric-medical-devices/

With regard to the pediatric consortia, GAO found that the pediatric device consortia created under FDAAA assisted 107 pediatric device projects in the first two …