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.
We have adjusted the number of
responses to reflect current data and trends. In addition, the
burden estimate has been updated consistent with new and amended
provisions. We corrected the burden table to include a line for the
"510(k) summary" under 21 CFR 807.92 which was inadvertently
omitted from the previous ICR submission. We are making available
form FDA 3881 noting that the information on this form was already
approved under the previous ICR submission. Form FDA 3514 was
revised and reformatted to improve usability and to be inclusive of
the majority of medical device product submission types. The
revisions made to this form eliminates the need for form FDA 3654.
Form FDA 3541 was removed from this ICR and the burden adjusted
accordingly. To this ICR we add the availability of the eSTAR forms
FDA 4062 and FDA 4078 (for IVD 510(k) to facilitate the preparation
of submissions in electronic format. Additionally, we are revising
this ICR to include two guidance documents, "Refuse to Accept
Policy for 510(k)s" and, "Request for Recogniction of a Voluntary
Consensus Standard." Further details on these updates, revisions
and adjustments may be found in item A15 of the supporting
statement.
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.
Premarket Notification Submission 510(k), Subpart E