Matches in SemOpenAlex for { <https://semopenalex.org/work/W4281645452> ?p ?o ?g. }
Showing items 1 to 85 of
85
with 100 items per page.
- W4281645452 endingPage "667" @default.
- W4281645452 startingPage "658" @default.
- W4281645452 abstract "Orthopaedic devices account for nearly 20% of all devices on the market, with more than 600 novel orthopaedic devices cleared or approved by the FDA for marketing in the United States annually. Advances in technology and biologic therapies offer tremendous potential for patients with musculoskeletal ailments; however, it is important that the safety and effectiveness of these products be assessed to safeguard the public health. The FDA uses multiple different premarket pathways for devices, biologics, and combination products based on perceived risk of the novel product. More than 97% of orthopaedic devices go through the FDA's 510(k) pathway, which does not require clinical trials. The remaining high-risk devices must receive premarket approval and submit clinical trial data demonstrating safety and effectiveness. Similarly, high-risk biologics must obtain a biologics license application by submitting clinical trial data. Postmarketing surveillance strategies, including extended clinical trials or real-world evidence from registries, are increasingly being relied on by the FDA to expedite approval while also improving its capacity to identify problematic products." @default.
- W4281645452 created "2022-06-13" @default.
- W4281645452 creator A5003219613 @default.
- W4281645452 creator A5028415689 @default.
- W4281645452 creator A5047332486 @default.
- W4281645452 creator A5062468132 @default.
- W4281645452 date "2022-06-02" @default.
- W4281645452 modified "2023-10-14" @default.
- W4281645452 title "The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology" @default.
- W4281645452 cites W124099486 @default.
- W4281645452 cites W1936293579 @default.
- W4281645452 cites W2022102342 @default.
- W4281645452 cites W2079818508 @default.
- W4281645452 cites W2092532207 @default.
- W4281645452 cites W2124783107 @default.
- W4281645452 cites W2174920330 @default.
- W4281645452 cites W2325074440 @default.
- W4281645452 cites W2398670377 @default.
- W4281645452 cites W2461046665 @default.
- W4281645452 cites W2611601453 @default.
- W4281645452 cites W2799391653 @default.
- W4281645452 cites W2901688569 @default.
- W4281645452 cites W3127524761 @default.
- W4281645452 cites W3159319665 @default.
- W4281645452 cites W3212072236 @default.
- W4281645452 doi "https://doi.org/10.5435/jaaos-d-22-00179" @default.
- W4281645452 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/35797679" @default.
- W4281645452 hasPublicationYear "2022" @default.
- W4281645452 type Work @default.
- W4281645452 citedByCount "2" @default.
- W4281645452 countsByYear W42816454522023 @default.
- W4281645452 crossrefType "journal-article" @default.
- W4281645452 hasAuthorship W4281645452A5003219613 @default.
- W4281645452 hasAuthorship W4281645452A5028415689 @default.
- W4281645452 hasAuthorship W4281645452A5047332486 @default.
- W4281645452 hasAuthorship W4281645452A5062468132 @default.
- W4281645452 hasConcept C112930515 @default.
- W4281645452 hasConcept C126894567 @default.
- W4281645452 hasConcept C138944611 @default.
- W4281645452 hasConcept C142724271 @default.
- W4281645452 hasConcept C17744445 @default.
- W4281645452 hasConcept C197636746 @default.
- W4281645452 hasConcept C197934379 @default.
- W4281645452 hasConcept C199539241 @default.
- W4281645452 hasConcept C2780035454 @default.
- W4281645452 hasConcept C2780560020 @default.
- W4281645452 hasConcept C2992293740 @default.
- W4281645452 hasConcept C535046627 @default.
- W4281645452 hasConcept C71924100 @default.
- W4281645452 hasConcept C98274493 @default.
- W4281645452 hasConceptScore W4281645452C112930515 @default.
- W4281645452 hasConceptScore W4281645452C126894567 @default.
- W4281645452 hasConceptScore W4281645452C138944611 @default.
- W4281645452 hasConceptScore W4281645452C142724271 @default.
- W4281645452 hasConceptScore W4281645452C17744445 @default.
- W4281645452 hasConceptScore W4281645452C197636746 @default.
- W4281645452 hasConceptScore W4281645452C197934379 @default.
- W4281645452 hasConceptScore W4281645452C199539241 @default.
- W4281645452 hasConceptScore W4281645452C2780035454 @default.
- W4281645452 hasConceptScore W4281645452C2780560020 @default.
- W4281645452 hasConceptScore W4281645452C2992293740 @default.
- W4281645452 hasConceptScore W4281645452C535046627 @default.
- W4281645452 hasConceptScore W4281645452C71924100 @default.
- W4281645452 hasConceptScore W4281645452C98274493 @default.
- W4281645452 hasIssue "14" @default.
- W4281645452 hasLocation W42816454521 @default.
- W4281645452 hasLocation W42816454522 @default.
- W4281645452 hasOpenAccess W4281645452 @default.
- W4281645452 hasPrimaryLocation W42816454521 @default.
- W4281645452 hasRelatedWork W168688824 @default.
- W4281645452 hasRelatedWork W2029003529 @default.
- W4281645452 hasRelatedWork W2329376453 @default.
- W4281645452 hasRelatedWork W2353262041 @default.
- W4281645452 hasRelatedWork W2782320850 @default.
- W4281645452 hasRelatedWork W2958985628 @default.
- W4281645452 hasRelatedWork W3016368147 @default.
- W4281645452 hasRelatedWork W4205647419 @default.
- W4281645452 hasRelatedWork W4281645452 @default.
- W4281645452 hasRelatedWork W90790054 @default.
- W4281645452 hasVolume "30" @default.
- W4281645452 isParatext "false" @default.
- W4281645452 isRetracted "false" @default.
- W4281645452 workType "article" @default.