MANUFACTURERS WHO WISH TO DISTRIBUTE
NEW OR CHANGED MEDICAL DEVICES MU SUBMIT A PREMARKET NOTIFICATION
TO FDA 90 DAYS BEFORE GOING TO MARKET. FDA EXAMINES THIS
NOTIFICATION AND DETERMINES IF THE PRODUCT IS OR IS NOT
SUBSTANTIALLY EQUIVALENT TO A PRE-AMENDMENTS DEVICE. THOSE THA ARE
EQUIVALENT MAY BE MARKETED IMMEDIATELY AND THOS WHICH ARE NOT MAY
NOT BE MARKETED WITHOUT FURTHER EVALUATIONS.
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.