Biomedical Engineering Reference
In-Depth Information
control treatment must be recognized as the current standard of care for
this patient population
°
description of how uniformity of the control and experimental treat-
ments will be maintained across the investigational sites must be
provided
°
*
post-treatment regimen
°
description of the follow-up schedule must be provided
frequency of the follow-up visits as well as a description of treatment
˜
all laboratory testing
˜
all treatments and evaluations
°
*
device effectiveness evaluation
°
study endpoints must be clearly identified
rationale for the selection of these endpoints
°
parameters used to evaluate the effectiveness of the dressing in the
management of the indicated wound
°
comparison of standard care
°
*
effectiveness evaluation
°
validated evaluation scales
histology of the tissue repaired
°
long term follow-up
°
patient and investigator evaluations
°
photographs (if indicated) evaluated by a panel of masked evaluators
°
radiographs, MRIs, and so on evaluated by a panel of masked evalua-
tors
°
patient satisfaction/quality of life scale using validated measurement
tool
°
any other treatment effectiveness evaluation evaluated by a panel of
masked evaluators
°
*
post-approval requirements
°
post-approval study or post-market surveillance study if indicated to
collect additional information about the safety, effectiveness and reli-
ability of the product
restriction on the sale and distribution of a product because of a high
risk of harm or the need for collateral measures to ensure safe and
effective use
°
requirement to add a prominent display of warnings, hazards, and
precautions necessary for safe and effective use of labeling and to the
advertising of restricted product
°
requirement to include identification codes on the product, in its
labeling or on card given to patients with implants, if necessary to
protect public health (if indicated)
°
requirement to maintain product tracking records in order to trace
patients, if it becomes necessary to protect public health (if indicated)
°
