Matches in SemOpenAlex for { <https://semopenalex.org/work/W4297935445> ?p ?o ?g. }
Showing items 1 to 52 of
52
with 100 items per page.
- W4297935445 endingPage "8" @default.
- W4297935445 startingPage "19650" @default.
- W4297935445 abstract "The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a generic type of medical device intended for the treatment of erectile dysfunction. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. This action is being taken 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." @default.
- W4297935445 created "2022-10-01" @default.
- W4297935445 date "2000-04-12" @default.
- W4297935445 modified "2023-09-29" @default.
- W4297935445 title "Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule." @default.
- W4297935445 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/11010632" @default.
- W4297935445 hasPublicationYear "2000" @default.
- W4297935445 type Work @default.
- W4297935445 citedByCount "0" @default.
- W4297935445 crossrefType "journal-article" @default.
- W4297935445 hasConcept C136229726 @default.
- W4297935445 hasConcept C144133560 @default.
- W4297935445 hasConcept C17744445 @default.
- W4297935445 hasConcept C199539241 @default.
- W4297935445 hasConcept C2779913896 @default.
- W4297935445 hasConcept C2780035454 @default.
- W4297935445 hasConcept C2987276129 @default.
- W4297935445 hasConcept C3018890749 @default.
- W4297935445 hasConcept C3020535179 @default.
- W4297935445 hasConcept C71924100 @default.
- W4297935445 hasConcept C98274493 @default.
- W4297935445 hasConceptScore W4297935445C136229726 @default.
- W4297935445 hasConceptScore W4297935445C144133560 @default.
- W4297935445 hasConceptScore W4297935445C17744445 @default.
- W4297935445 hasConceptScore W4297935445C199539241 @default.
- W4297935445 hasConceptScore W4297935445C2779913896 @default.
- W4297935445 hasConceptScore W4297935445C2780035454 @default.
- W4297935445 hasConceptScore W4297935445C2987276129 @default.
- W4297935445 hasConceptScore W4297935445C3018890749 @default.
- W4297935445 hasConceptScore W4297935445C3020535179 @default.
- W4297935445 hasConceptScore W4297935445C71924100 @default.
- W4297935445 hasConceptScore W4297935445C98274493 @default.
- W4297935445 hasIssue "71" @default.
- W4297935445 hasLocation W42979354451 @default.
- W4297935445 hasOpenAccess W4297935445 @default.
- W4297935445 hasPrimaryLocation W42979354451 @default.
- W4297935445 hasRelatedWork W2011444787 @default.
- W4297935445 hasRelatedWork W2035800514 @default.
- W4297935445 hasRelatedWork W2088379657 @default.
- W4297935445 hasRelatedWork W2100022978 @default.
- W4297935445 hasRelatedWork W2341166473 @default.
- W4297935445 hasRelatedWork W2416279706 @default.
- W4297935445 hasRelatedWork W2595345650 @default.
- W4297935445 hasRelatedWork W2738558309 @default.
- W4297935445 hasRelatedWork W3044084586 @default.
- W4297935445 hasRelatedWork W4254161854 @default.
- W4297935445 hasVolume "65" @default.
- W4297935445 isParatext "false" @default.
- W4297935445 isRetracted "false" @default.
- W4297935445 workType "article" @default.