This information collection requires a
person who intends to market a medical device to submit premarket
notification submission to FDA as least 90 days before proposing to
begin the introduction, or delivery for introduction into
interstate commerce, for commercial distribution of a device
intended for human use. The information collected in a premarket
notification allows for scientific and/or medical review of
devices, subject to section 510(k) of the act, to confirm that the
new devices are as safe and as effective as legally marketed
predicate devices.
FDA is submitting this
nonmaterial/nonsubstantive change request (83c) in order to reduce
the burden estimate for OMB control number 0910-0120, Premarket
Notification (510(k)), by 4 responses and 182 hours. This request
is being made to reflect the burden shift between the Premarket
Notification (510(k)) ICR (0910-0120) and the Premarket Approval of
Medical Devices ICR (0910-0231) due to the reclassification of
medical devices under section 515(i) of the Federal Food, Drug, and
Cosmetic Act.
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.