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.
The estimated annual burden for
this collection of information has decreased(adjustment). The
number of 510 (K) submissions has been decreasing each year, and is
projected to decrease further in the future due to FDAMA, MDUFMA,
product reclassification efforts, and CDRH reengineering and
strategic efforts. The burden has changed due to the decrease in
the number of submissions received from respondents as more 510 (K
) device exemptions have been granted. FDA now estimates that it
will receive about 3,700 510 (K) submissions per year. The total
estimated burden hours for completion of a premarket notification
have therefore been reduced. The burden for this collection has
decreased by 55,472 hours due to the reduction in the number of
premarket notifications expected in a year. In addition, there was
an adjustment made to correct an error in which 21 CFR 807.93 was
incorrectly identified as a recordkeeping requirement but has been
correctly changed to a reporting requirement. This change
(adjustment) did not result in a change to the original burden
estimate. This action was discussed and confirmed in discussions
with Seleda Perryman, HHS Reports Clearance Officer.
$20,009
No
Yes
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
No
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.