This information
collection is approved for one year under the condition that FDA
study the feasibility of accepting 510(k) submissions
electronically and on floppy disks. The study should include an
examination of the purely technical as well as the logistic
procedures necessary to update FDA's review process.
Inventory as of this Action
Requested
Previously Approved
05/31/1993
05/31/1993
5,400
0
0
87,600
0
0
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.