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Expedited Category #4
Collection of data through noninvasive procedures (not
involving general anesthesia or sedation) routinely employed
in clinical
practice, excluding procedures involving x-rays or microwaves.
Where medical devices are employed, they must be cleared/approved
for marketing. (Studies intended to evaluate the safety and
effectiveness of medical devices are not generally eligible
for expedited review,
including studies of cleared medical devices for new indications.)
Examples include the following:
- physical sensors that are
applied either to the surface of the body or at a distance
and do not involve input of
significant amounts of energy into the subject or
an invasion of the subject’s
privacy;
- weighing or testing sensory acuity;
- magnetic resonance
imaging;
- electrocardiography, electroencephalography, thermography,
detection of naturally occurring radioactivity,
electroretinography, ultrasound, diagnostic infrared imaging,
doppler blood
flow, and echocardiography.
- moderate exercise, muscular
strength testing, body composition assessment, and flexibility
testing where
appropriate given
the age, weight, and health of the individual.
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