This ICR collects information from
persons who intend to market a medical device. Based on the
information provided in the premarket notification (510(k))
submission, FDA determines whether a new device provides reasonable
assurance of the safety and effectiveness of the device through
substantial equivalence to a legally marketed device and whether
the device can, therefore, be allowed to enter the U.S. market.
Because the review of 510(k) submissions confirms that the new
device is as safe and as effective as legally marketed predicate
devices, potentially unsafe and/or ineffective devices, including
those with fraudulent claims, are prevented from entering the U.S.
market.
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.