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FDA will waive those requirements regarding submission and prior
FDA approval of a supplemental application and receipt of certification
of institutional review board (IRB) approval for the addition
of investigational sites [21 CFR 812.35(b)] provided:
a. the names and addresses of all investigational sites,
b. the names and addresses of all investigators, identifying those
who are currently participating,
c. the names, addresses and chairpersons of all IRBs,
d. the dates of IRB approvals, and
e. the dates of first shipment or first use of investigational
devices for all participating institutions.
If you agree to these conditions, you may begin an investigation
at a new investigational site after the IRB has approved the investigation.
No documentation should be submitted for any institution within
the approved limit until the investigational site limit is reached
or the 6month current investigator list is due. FDA assumes
that you have agreed to the conditions of this waiver unless you
specifically notify us in writing of your disagreement. Please
note, however, that you must submit a supplemental IDE application,
and receive FDA approval, prior to expanding the investigation
beyond the limit specified above. Additionally, if you do not
agree to these conditions, you must comply with the full requirements
for the submission to FDA of a supplemental IDE application for
new investigational sites not already specifically approved for
participation in your study (21 CFR 812.35(b)).
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Center for Devices and Radiological Health / CDRH