Section 201 of the Food and Drug
Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115)
amended the Federal Food, Drug, and Cosmetic Act to provide that
sponsors of investigational devices may make developmental changes
in a device or changes to the protocol that do not affect the
validity of the data, the soundness of the investigational plan, or
the safety or welfare of patients without FDA approval provided
that the sponsor notifies FDA within 5 days after making the
change. The sponsor would be required to submit information about
the nature of the change and how it meets....
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.