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FDA Medical Device Reviews: Evaluation is Needed to …
- https://www.gao.gov/products/gao-18-140
- GAO found that, from 2001 through 2016, FDA issued letters asking sponsors to provide such information for a majority of the more than 62,000 medical device submissions that it reviewed. Sponsors may formally disagree with the request on the …
Medical Devices: - U.S. Government Accountability …
- https://www.gao.gov/products/gao-12-816
- In this report, GAO (1) identifies the threats, vulnerabilities, and resulting information security risks associated with active implantable medical devices, (2) …
Medical Devices: - U.S. Government Accountability …
- https://www.gao.gov/products/gao-15-815
- On average, manufacturers completed postapproval studies in about 3 years, with the longest study taking almost 7 years, for the studies that GAO reviewed. Ninety …
Medical Devices: - U.S. Government Accountability …
- https://www.gao.gov/products/gao-11-556t
- The Food and Drug Administration (FDA) is responsible for overseeing medical devices sold in the United States. In general, new devices are subject to FDA …
GAO-15-815, Medical Devices: FDA Ordered …
- https://www.gao.gov/assets/gao-15-815.pdf
- 1Medical devices include instruments, apparatuses, machines, and implants that are intended for use to diagnose, cure, treat, or prevent disease, or to affect the structure or …
February 2017 MEDICAL DEVICES - gao.gov
- https://www.gao.gov/assets/gao-17-231.pdf
- FDA’s oversight of medical devices begins before a new device is brought to the market and continues after a device is on the market. For most medical devices that require …
August 2012 MEDICAL DEVICES - Government …
- https://www.gao.gov/pdf/product/647767
- In this report, GAO (1) identifies the threats, vulnerabilities, and resulting information security risks associated with active implantable medical devices, (2) determines the …
Medical Devices: - U.S. Government Accountability …
- https://www.gao.gov/products/pemd-87-1
- In response to a congressional request, GAO provided information on the communications network and its flow patterns for problems associated with medical devices that the …
DeLauro: New GAO Report Shows FDA Must Do More …
- http://delauro.house.gov/media-center/press-releases/delauro-new-gao-report-shows-fda-must-do-more-ensure-medical-device
- WASHINGTON, DC—A Government Accountability Office (GAO) report released today showed that the Food and Drug Administration (FDA) must do more to …
FDA’s inspection backlog: GAO raises concerns as …
- https://www.raps.org/news-and-articles/news-articles/2021/3/fdas-inspection-backlog-gao-raises-concerns-as-del
- GAO’s report, submitted as testimony to the hearing, finds that “if inspections continue to be postponed, the backlog of mandatory inspections this will create could …
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