This ICR collects information from
manufacturers of custom devices through submission of an annual
report to FDA that identifies the number of new custom devices unit
manufactured and distributed per year. Based on the information
provided in the annual report, FDA will determine whether a device
continues to meet the qualifications for a custom device exemption.
Also, the annual reports will allow FDA to assess several important
issues related to the description and use of the custom device in
patients and physicians. As a result, manufacturers developing a
custom device for a product not generally available in the United
States and meet the requirements defined in section 520(b) of
FD&C Act, will be required to develop and submit an annual
report for the maximum five units per year of a particular device
type.
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.