THIS INFORMATION
COLLECTION IS APPROVED THROUGH 2/85 SUBJECT TO THE CONDITION THAT
FDA COMPLETE TWO WORK PRODUCTS. FIRST, FDA MUST DEVELO CRITERIA
WHICH CLEARLY PRESCRIBE THE CONDITIONS UNDER WHICH THE 510(K)
NOTIFICATION REQUIREMENTS WILL BE WAIVED BY THE AGENCY. SECOND FDA
MUST COMPLETE THE DEVELOPMENT OF CLEARER INSTRUCTIONS SETTING FORTH
THE DATA SUBMISSION REQUIREMENTS IN CASES IN WHICH A 510(K)
NOTIFICATION IS REQUIRED. BOTH OF THESE PRODUCTS HAVE BEEN UNDER
DEVELOPMENT AT FDA FOR OVER A YEAR, AND MUST BE FINALIZED BY THE
EXPIRATION DATE. FAILURE TO PROVIDE THESE DOCUMENTS BY THIS
DEADLINE WILL RESULT IN OMB REQUIRING THE INITIATION OF A
RULEMAKING UNDER 5CFR1320.14(F).
Inventory as of this Action
Requested
Previously Approved
02/28/1985
02/28/1985
5,000
0
0
76,000
0
0
0
0
0
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.