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- Investigational_Device_Exemption abstract "An Investigational Device Exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study) to be used in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or aPremarket Notification [510(k)] submission to Food and Drug Administration (FDA). Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.Clinical evaluation of devices that have not been cleared for marketing requires:An IDE approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDAInformed consent from all patientsLabeling for investigational use onlyMonitoring of the study andRequired records and reportsAn approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would apply to devices in commercial distribution. Sponsors need not submit a PMA or Premarket Notification, register their establishment, or list the device while the device is under investigation. Sponsors of IDE's are also exempt from the Quality System (QS) Regulation except for the requirements for design control.A sponsor of a significant risk device study must submit a complete IDE application to FDA. There are no preprinted forms for an IDE application; however, an IDE application must include certain required information. The sponsor must demonstrate in the application that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.".
- Investigational_Device_Exemption wikiPageID "2312560".
- Investigational_Device_Exemption wikiPageLength "3085".
- Investigational_Device_Exemption wikiPageOutDegree "16".
- Investigational_Device_Exemption wikiPageRevisionID "682372903".
- Investigational_Device_Exemption wikiPageWikiLink Academic_clinical_trial.
- Investigational_Device_Exemption wikiPageWikiLink Adverse_drug_reaction.
- Investigational_Device_Exemption wikiPageWikiLink Adverse_event.
- Investigational_Device_Exemption wikiPageWikiLink Approved_drug.
- Investigational_Device_Exemption wikiPageWikiLink Assay_sensitivity.
- Investigational_Device_Exemption wikiPageWikiLink Biotechnology.
- Investigational_Device_Exemption wikiPageWikiLink Category:American_medical_research.
- Investigational_Device_Exemption wikiPageWikiLink Category:Pharmaceutical_industry.
- Investigational_Device_Exemption wikiPageWikiLink Clinical_trial.
- Investigational_Device_Exemption wikiPageWikiLink Federal_Food,_Drug,_and_Cosmetic_Act.
- Investigational_Device_Exemption wikiPageWikiLink Food_and_Drug_Administration.
- Investigational_Device_Exemption wikiPageWikiLink Institutional_review_board.
- Investigational_Device_Exemption wikiPageWikiLink Marketing.
- Investigational_Device_Exemption wikiPageWikiLink Premarket_Approval.
- Investigational_Device_Exemption wikiPageWikiLink Sponsor_(commercial).
- Investigational_Device_Exemption wikiPageWikiLinkText "IDE".
- Investigational_Device_Exemption wikiPageWikiLinkText "Investigational Device Exemption".
- Investigational_Device_Exemption wikiPageUsesTemplate Template:Reflist.
- Investigational_Device_Exemption subject Category:American_medical_research.
- Investigational_Device_Exemption subject Category:Pharmaceutical_industry.
- Investigational_Device_Exemption type Industry.
- Investigational_Device_Exemption type Pharmaceutic.
- Investigational_Device_Exemption comment "An Investigational Device Exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study) to be used in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or aPremarket Notification [510(k)] submission to Food and Drug Administration (FDA). Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application.".
- Investigational_Device_Exemption label "Investigational Device Exemption".
- Investigational_Device_Exemption sameAs Q17130611.
- Investigational_Device_Exemption sameAs m.072__j.
- Investigational_Device_Exemption sameAs Q17130611.
- Investigational_Device_Exemption wasDerivedFrom Investigational_Device_Exemption?oldid=682372903.
- Investigational_Device_Exemption isPrimaryTopicOf Investigational_Device_Exemption.