This ICR collects information from
persons filing a PMA application or a PMA supplement with FDA for
approval of certain class III medical devices. The PMA regulation
establishes procedures that FDA utilizes in approving, denying, or
withdrawing approval of any PMA. It provides specific, clear, and
flexible instructions to applicants so those respondents know what
information is required in a PMA. PMA supplements are also used by
FDA to determine any additional action the agency must take to
protect the public health. The data reported to FDA and the records
that are maintained allow FDA and industry to make decisions and
take actions to protect the public health from defective medical
devices.
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.