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.
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.