Implantable devices: regulatory framework and reform options
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Insight on the issues (AARP Public Policy Institute)
- Author(s):
- Lind, Keith D., author
- Contributor(s):
- AARP (Organization), issuing body. Public Policy Institute (AARP (Organization)), issuing body.
- Publication:
- Washington, DC : AARP Public Policy Institute, August 2017
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Government Regulation Prostheses and Implants -- adverse effects Prostheses and Implants -- standards Clinical Trials as Topic Device Approval Equipment Failure Equipment Safety Product Surveillance, Postmarketing Registries Humans United States United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- Implantable devices, like cardiac pacemakers and artificial hip replacements, offer substantial benefits but can also pose serious risks. Against this backdrop of potential risk--and, in some cases, inadequate regulation--this Insight on the Issues focuses on the Food and Drug Administration's oversight of implantable devices and suggests reform options to help improve the existing regulatory framework. A second Insight on the Issues deals with the lack of price transparency and the need for greater competition in the marketplace for implantable devices.
- Copyright:
- Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY-NC-ND license. (More information)
- Extent:
- 1 online resource (1 PDF file (14 pages)).
- NLM Unique ID:
- 101747805 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101747805