Medical devices

Medical devices

Any instrument, appliance or machine that facilitates the prevention,diagnosis and treatment of illness, physical or mental injury, by a medical professional.

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Medical devices > Clinical trials

sponsor

Medical devices; Clinical trials

The organization or person who oversees the clinical study and is responsible for analyzing the study data.

registration

Medical devices; Clinical trials

The process of submitting and updating summary information about a clinical study protocol from its beginning to end, to a structured, Web-based registry that is accessible to the ...

masking

Medical devices; Clinical trials

A clinical trial design strategy in which one or more parties involved with the trial, such as the investigator or participant, do not know which participants have been assigned ...

no intervention arm

Medical devices; Clinical trials

A group of participants that does not receive any interventions during a clinical study. One of several arm types.

reporting group

Medical devices; Clinical trials

A grouping of participants in a clinical study that is used in summarizing the data collected during the study. This grouping may be the same as or different from a study arm.

observational study

Medical devices; Clinical trials

A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or ...

expanded access

Medical devices; Clinical trials

A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who ...