Solely for research definition

Solely for research means a service, procedure, or equipment which has not been approved by the Food and Drug Administration (FDA) but which is currently undergoing review by the FDA as an investigational device. FDA research protocol and any applicable Investigational Device Exemption (IDE) policies and regulations must be followed by a facility proposing a project “solely for research”.
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Solely for research means a service, procedure, or equipment which has not been approved
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Solely for research means a service, procedure, or equipment which has not been approved by the Food and Drug Administration (FDA) but which is currently undergoing review by the FDA as an investigational device. FDA research protocol and any applicable Investigational Device Exemption
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More Definitions of Solely for research

Solely for research means a service, procedure, or equipment which has not been approved by the Food and Drug Administration (FDA) but which is currently undergoing review by the FDA as an investigational device. FDA research protocol and any applicable Investigational Device Exemption (IDE) policies and regulations must be followed by a facility proposing a project 'solely for research'. 'Service area' means that geographic area specified in the State Health Plan which is determined by population data, patient origin data, or area health facilities offering services to the area. This service area is used in planning for specified health facilities and services and is to be used when considering applications to provide health facilities and services.
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Related to Solely for research

  • Delaware LLC Act means the Delaware Limited Liability Company Act.

  • General Partner means the Company or its successors as general partner of the Partnership.

  • Partnership means the limited partnership formed under the Act and pursuant to this Agreement, and any successor thereto.