Reinstatement with change of a previously approved collection
No
Regular
07/30/2025
Requested
Previously Approved
36 Months From Approved
3,657,936
0
547,263
0
18,710
0
This ICR collects information from
medical device manufacturers, importers, and user facilities that
are required to submit electronic and paper medical device reports
(MDRs) to the Food and Drug Administration (FDA) and to maintain
records, and who may also seek exemption from these requirements.
The information that is obtained from these reports will be used to
evaluate risks associated with medical devices and enable FDA to
take appropriate regulatory measures to protect the public health.
Complete, accurate, and timely adverse event information is
necessary for the identification of emerging device problems so the
Agency can protect the public health under the FD&C
Act.
Since the last extension of
this information collection, approved in 2021, we have updated the
supporting statement to include an approved revision (2022) which
reflects reporting requirements for certain Human Immunodeficiency
Virus (HIV) serological diagnostic and supplemental tests (at 21
CFR 866.3956) and for HIV nucleic acid tests (NATs) diagnostic and
supplemental tests (at 21 CFR 866.3957). Additionally, we have
included burden attributable to provisions set forth in 21 CFR part
4 subpart B, as approved in March 2023 (via nonsubstantive change
request), which were previously accounted for in OMB control number
0910-0834 (now discontinued) and are included in the burden
estimates above. We also adjusted the Average Burden per Response
for “Exemptions—803.19” and “Importer Reporting, Death and Serious
Injury--803.40 and 803.42” from 0.1 hour to 1 hour to correct an
error introduced in a previous request for extension of this
information collection. These adjustments have resulted in an
overall increase of 1,527,443 total responses, and a corresponding
increase of 323,806 total burden hours. We are revising this
information collection to add the FDA guidance entitled “Voluntary
Malfunction Summary Reporting (VMSR) Program for Manufacturers”
which is intended to help manufacturers better understand and use
the VMSR Program. The guidance does not affect the burden
estimates.
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.
Reporting; Manufacturer Reporting-- 803.50 through 803.53