This ICR collects information from
manufacturers, importers, and distributors of medical devices to
disclose to health professionals and consumers specific information
about themselves or their devices on the label or labeling of their
devices. The primary users of the information disclosed on the
label or in the labeling of devices are the health professionals
who use or prescribe the device or the lay consumers who use the
device. The labeling should contain sufficient information for
these persons to use the device safely and effectively. FDA may use
the information to determine whether there is reasonable assurance
of the safety and effectiveness of the device for its intended
use.
This information collection
reflects changes and adjustments. For efficiency of operations, we
have consolidated related information collections currently
approved under OMB control numbers 0910-0577 and 0910-0740. This
results in an increase to the information collection of 15,095
burden hours annually. The increase is due to adjustments
reflecting updated data and the inclusion of the consolidated
information collection. At the same time, we have reduced our
estimate of disclosure responses by 1,597,520 annually. Upon
review, we believe we previously double-counted burden ascribed to
disclosures provisions having accounted for the same burden as that
associated with recordkeeping activities. Finally, upon submission
of the ICR, we are correcting inadvertent calculation errors to the
burden hour increase and responses decrease displayed in our 60-day
notice. Specifically, additional burden hours have been added to
the third-party disclosure burden table to reflect an increase of
12,000 burden hours resulting in a total of 8,485,061 total burden
hours for the third-party disclosure burden. Also, additional
responses have been added resulting in a total increase in
responses of 21,647,170.
$2,633,260
No
No
No
No
No
No
No
Domini Bean 301 796-5733
domini.bean@fda.hhs.gov
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.
0485 Device Labeling SSA 2021 091721.pdf
Medical Device Labeling; Reporting