THE IDE REGULATIONS ESTABLISH
CONDITIONS AND PROCEDURES UNDER WHICH INVESTIGATIONS OF MEDICAL
DEVICES INVOLVING HUMAN SUBJECTS MAY BE EXEM FROM CERTAIN
REQUIREMENTS OF THE FD&C ACT. THE EXEMPTION PERMITS THE
INVESTIGATION USE OF MEDICAL DEVICES TO DETERMINE THEIR SAFETY AND
EFFECTIVENESS. SOME REGULATIONS IN THIS PACKAGE WERE PREVIOUSLY
CLEAR UNDER 0910-0195.
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.