THIS INFORMATION
COLLECTION IS APPROVED THROUGH 2/88. AS A CONDITION OF SUBSEQUENT
APPROVAL FDA SHOULD SUBMIT A COMPLETE INFORMATION REQUES THAT
INCLUDES A WRITTEN DESCRIPTION OF THE REVISED CRITERIA FOR THE
WAIVER OF 510(k) NOTIFTION REQUIREMENTS AND A DISCUSSION OF ON
GOING EFFORTS TO DEVELOP GUIDELINES FOR DEVICE OR CATEGORY SPECIFIC
DATA SUBMISSION REQUIREMENTS.
Inventory as of this Action
Requested
Previously Approved
02/28/1988
02/28/1988
12/31/1986
5,000
0
5,000
78,000
0
76,000
0
0
0
MANUFACTURER'S WISHING TO DISTRIBUTE
NE OR CHANGED MEDICAL DEVICES MUST SUBMIT A PREMARKET NOTIFICATION
TO FDA 90 DAYS BEFORE MARKETING. FDA REVIEWS THE NOTIFICATION AND
DETERMINES WHETHER THE PRODUCT IS SUBSTANTIALLY EQUIVALENT TO A
PRE-AMENDMENTS DEVICE. THOSE WHICH ARE EQUIVALENT MAY BE MARKETED
IMMEDIATELY, AND THOSE WHICH ARE NOT, MAY NOT BE MARKETED WITHOUT
FURTHER EVALUATIO
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.