Left to their own devices: breakdowns in United States medical device premarket review.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 20634922.
- Also identified by DOI 10.1371/journal.pmed.1000280 and PMC identifier 2903853.
- 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
Using examples from recent FDA regulatory proceedings, Jonas Hines and colleagues critique the medical device premarket review and identify eight weaknesses in the process that should be remedied.
Medical subject headings
- Device Approval
- Equipment and Supplies
- Legislation, Medical