This ICR collects information from
medical device manufactures who wish to request reclassification of
a medical device. A manufacturer may petition the Agency to
reclassify a device. The reclassification procedures regulation
requires a manufacturer to submit specific data when petitioning
for reclassification. This includes both a "supplemental data
sheet" (Form FDA 3427) and a "classification questionnaire" (Form
FDA 3429). Each of these forms contains a series of questions
concerning the safety and effectiveness of the device type. The
regulation requires device manufacturers to provide, in a petition
for device reclassification, specification of the type of device, a
statement of the action requested, and a justification for the
request to reclassify.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.