Matches in SemOpenAlex for { <https://semopenalex.org/work/W3208554199> ?p ?o ?g. }
Showing items 1 to 75 of
75
with 100 items per page.
- W3208554199 abstract "In the 43 years since the enactment of the Medical Device Regulation Act of 1976 (MDRA), the United States has devolved into a public health crisis emergency regarding medical device safety. Over the last decade, faulty or flawed medical devices have injured 1.7 million and killed nearly 83,000 people nationwide. This paper will argue that the country’s current medical device safety crisis is directly tied to the United States Food and Drug Administration’s (FDA) inadequate regulation of those products, the agency’s inadequate pre-market approval (PMA) process, corporate abuse of the FDA 510(k) pathway, and the FDA’s failure to engage in post market surveillance and enforcement that ensures the safety of the medical devices that it approves/clears. This paper reviews the major medical device regulatory oversight reforms that scholars have proposed over the last several decades and provides its own novel recommendations. Due to the recent enactment of the 21st Century Cures Act and the current Administration’s pro-deregulation posture, our medical device safety crisis is likely to continue to worsen unless reforms are enacted that demand that the FDA live up to its mission of protecting and advancing the public health." @default.
- W3208554199 created "2021-11-08" @default.
- W3208554199 creator A5030533515 @default.
- W3208554199 date "2020-03-19" @default.
- W3208554199 modified "2023-09-23" @default.
- W3208554199 title "Attack of the Clones: An Examination and Critique of FDA's Medical Device Regulatory Scheme" @default.
- W3208554199 hasPublicationYear "2020" @default.
- W3208554199 type Work @default.
- W3208554199 sameAs 3208554199 @default.
- W3208554199 citedByCount "0" @default.
- W3208554199 crossrefType "posted-content" @default.
- W3208554199 hasAuthorship W3208554199A5030533515 @default.
- W3208554199 hasConcept C108170787 @default.
- W3208554199 hasConcept C111472728 @default.
- W3208554199 hasConcept C112930515 @default.
- W3208554199 hasConcept C136229726 @default.
- W3208554199 hasConcept C138885662 @default.
- W3208554199 hasConcept C139719470 @default.
- W3208554199 hasConcept C144133560 @default.
- W3208554199 hasConcept C162324750 @default.
- W3208554199 hasConcept C17744445 @default.
- W3208554199 hasConcept C199539241 @default.
- W3208554199 hasConcept C2777351259 @default.
- W3208554199 hasConcept C2779777834 @default.
- W3208554199 hasConcept C2780765947 @default.
- W3208554199 hasConcept C3018890749 @default.
- W3208554199 hasConcept C3020535179 @default.
- W3208554199 hasConcept C3116431 @default.
- W3208554199 hasConcept C71924100 @default.
- W3208554199 hasConcept C78780426 @default.
- W3208554199 hasConceptScore W3208554199C108170787 @default.
- W3208554199 hasConceptScore W3208554199C111472728 @default.
- W3208554199 hasConceptScore W3208554199C112930515 @default.
- W3208554199 hasConceptScore W3208554199C136229726 @default.
- W3208554199 hasConceptScore W3208554199C138885662 @default.
- W3208554199 hasConceptScore W3208554199C139719470 @default.
- W3208554199 hasConceptScore W3208554199C144133560 @default.
- W3208554199 hasConceptScore W3208554199C162324750 @default.
- W3208554199 hasConceptScore W3208554199C17744445 @default.
- W3208554199 hasConceptScore W3208554199C199539241 @default.
- W3208554199 hasConceptScore W3208554199C2777351259 @default.
- W3208554199 hasConceptScore W3208554199C2779777834 @default.
- W3208554199 hasConceptScore W3208554199C2780765947 @default.
- W3208554199 hasConceptScore W3208554199C3018890749 @default.
- W3208554199 hasConceptScore W3208554199C3020535179 @default.
- W3208554199 hasConceptScore W3208554199C3116431 @default.
- W3208554199 hasConceptScore W3208554199C71924100 @default.
- W3208554199 hasConceptScore W3208554199C78780426 @default.
- W3208554199 hasLocation W32085541991 @default.
- W3208554199 hasOpenAccess W3208554199 @default.
- W3208554199 hasPrimaryLocation W32085541991 @default.
- W3208554199 hasRelatedWork W1579249821 @default.
- W3208554199 hasRelatedWork W1844802243 @default.
- W3208554199 hasRelatedWork W1980625173 @default.
- W3208554199 hasRelatedWork W2001602040 @default.
- W3208554199 hasRelatedWork W2024887596 @default.
- W3208554199 hasRelatedWork W2033418665 @default.
- W3208554199 hasRelatedWork W2038769066 @default.
- W3208554199 hasRelatedWork W2057173920 @default.
- W3208554199 hasRelatedWork W2094489892 @default.
- W3208554199 hasRelatedWork W2178051306 @default.
- W3208554199 hasRelatedWork W2775562134 @default.
- W3208554199 hasRelatedWork W2953927967 @default.
- W3208554199 hasRelatedWork W2954530203 @default.
- W3208554199 hasRelatedWork W2969137655 @default.
- W3208554199 hasRelatedWork W3121480233 @default.
- W3208554199 hasRelatedWork W3125515911 @default.
- W3208554199 hasRelatedWork W3188274719 @default.
- W3208554199 hasRelatedWork W3189404662 @default.
- W3208554199 hasRelatedWork W2092501664 @default.
- W3208554199 hasRelatedWork W2133024580 @default.
- W3208554199 isParatext "false" @default.
- W3208554199 isRetracted "false" @default.
- W3208554199 magId "3208554199" @default.
- W3208554199 workType "article" @default.