Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011.
cross_sectional · Level IV
Where this comes from
- Record sourced from PubMed, PMID 32857145.
- Also identified by DOI 10.1001/jamanetworkopen.2020.14496 and PMC identifier 7455850.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
This cross-sectional study provides a 5-year update on the status and availability of postmarket evidence for high-risk medical devices that received FDA premarket approval in 2010 and 2011.
Medical subject headings
- Clinical Trials as Topic
- Device Approval
- Product Surveillance, Postmarketing
- Prostheses and Implants