Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020.
cross_sectional · Level IV
Where this comes from
- Record sourced from PubMed, PMID 34152383.
- Also identified by DOI 10.1001/jamainternmed.2021.3042 and PMC identifier 8218229.
- No licence information is recorded for this record.
- Because redistribution is not established, this page shows the abstract only. Follow the links below for the full text.
Abstract
This cross-sectional study explores the frequency of, and rationale for, US Food and Drug Administration approval of high-risk therapeutic medical devices not meeting pivotal study primary end points from 2016 through 2020.
Medical subject headings
- Device Approval