The Medical Device Amendments of 1976
to the Federal Food, Drug, and Cosmetic Act (the Act) established
three regulatory classes for medical devices. Class III devices are
ones which support or sustain human life, or are of substantial
importance in preventing impairment of human health or present a
potential, unreasonable risk of illness or injury. Under Section
515 of the act, all Class II devices are subject to premarket
approval requirements. An approved Premarket Approval Application
(PMA) is, in effect, a private license granted to the applicant for
marketing a particular medical device. A Class III
device.....
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.