Matches in SemOpenAlex for { <https://semopenalex.org/work/W4300368377> ?p ?o ?g. }
Showing items 1 to 58 of
58
with 100 items per page.
- W4300368377 endingPage "90" @default.
- W4300368377 startingPage "67789" @default.
- W4300368377 abstract "The Food and Drug Administration (FDA) is classifying the transcutaneous air conduction hearing aid system (TACHAS) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device." @default.
- W4300368377 created "2022-10-03" @default.
- W4300368377 date "2002-11-07" @default.
- W4300368377 modified "2023-09-29" @default.
- W4300368377 title "Medical devices; ear, nose, and throat devices; classification of the transcutaneous air conduction hearing aid system. Final rule." @default.
- W4300368377 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/12422884" @default.
- W4300368377 hasPublicationYear "2002" @default.
- W4300368377 type Work @default.
- W4300368377 citedByCount "0" @default.
- W4300368377 crossrefType "journal-article" @default.
- W4300368377 hasConcept C108170787 @default.
- W4300368377 hasConcept C111472728 @default.
- W4300368377 hasConcept C136229726 @default.
- W4300368377 hasConcept C138885662 @default.
- W4300368377 hasConcept C144133560 @default.
- W4300368377 hasConcept C17744445 @default.
- W4300368377 hasConcept C199539241 @default.
- W4300368377 hasConcept C2780765947 @default.
- W4300368377 hasConcept C2780801066 @default.
- W4300368377 hasConcept C3018890749 @default.
- W4300368377 hasConcept C3020535179 @default.
- W4300368377 hasConcept C545542383 @default.
- W4300368377 hasConcept C548259974 @default.
- W4300368377 hasConcept C71924100 @default.
- W4300368377 hasConceptScore W4300368377C108170787 @default.
- W4300368377 hasConceptScore W4300368377C111472728 @default.
- W4300368377 hasConceptScore W4300368377C136229726 @default.
- W4300368377 hasConceptScore W4300368377C138885662 @default.
- W4300368377 hasConceptScore W4300368377C144133560 @default.
- W4300368377 hasConceptScore W4300368377C17744445 @default.
- W4300368377 hasConceptScore W4300368377C199539241 @default.
- W4300368377 hasConceptScore W4300368377C2780765947 @default.
- W4300368377 hasConceptScore W4300368377C2780801066 @default.
- W4300368377 hasConceptScore W4300368377C3018890749 @default.
- W4300368377 hasConceptScore W4300368377C3020535179 @default.
- W4300368377 hasConceptScore W4300368377C545542383 @default.
- W4300368377 hasConceptScore W4300368377C548259974 @default.
- W4300368377 hasConceptScore W4300368377C71924100 @default.
- W4300368377 hasIssue "216" @default.
- W4300368377 hasLocation W43003683771 @default.
- W4300368377 hasOpenAccess W4300368377 @default.
- W4300368377 hasPrimaryLocation W43003683771 @default.
- W4300368377 hasRelatedWork W1946493531 @default.
- W4300368377 hasRelatedWork W2044183094 @default.
- W4300368377 hasRelatedWork W2044330523 @default.
- W4300368377 hasRelatedWork W2080782197 @default.
- W4300368377 hasRelatedWork W2089619274 @default.
- W4300368377 hasRelatedWork W2394832826 @default.
- W4300368377 hasRelatedWork W4291234085 @default.
- W4300368377 hasRelatedWork W4298269493 @default.
- W4300368377 hasRelatedWork W4298872860 @default.
- W4300368377 hasRelatedWork W4299860643 @default.
- W4300368377 hasVolume "67" @default.
- W4300368377 isParatext "false" @default.
- W4300368377 isRetracted "false" @default.
- W4300368377 workType "article" @default.