FDA HAS PROPOSED
A FOUR-PRONGED APPROACH TO REDUCING PAPERWORK BURDENS ASSOCIATED
WITH THE 510 (k) PROCESS. FIRST, FDA WILL PURSUE THE DEVELOPMENT OF
COMPREHENSIVE CRITERIA TO DETERMINE WHEN AN EXEMPTION FOR 510(K)
PROCEDURES IS APPROPRIATE. SECOND, ONCE DEVELOPED, FDA WILL APPLY
THESE CRITERIA TO DEVICES THAT HAVE ALREADY BEEN CLASSIFIED IN
FINAL REGULATIONS, AND WILL REVISE THESE REGULATIONS AS APPROPRIATE
THIRD, BEGINNING IMMEDIATELY FDA WILL BE MORE LIBERAL IN GRANTING
510(K) WAIVERS AS DEVICES ARE PROPOSED FOR FINAL CLASSIFICATION.
FOURTH, FDA WILL DEVELOP CLEARER INSTRUCTIONS DESCRIBING WHAT WOULD
CONSTITUTE APPROPRIATE CONTENT FOR SUBMISSION OF PREMARKET
NOTIFICATIO IN VIEW OF FDA's PROPOSALS DESIGNED TO PROVIDE
PAPERWORK RELIEF, OMB HAS GRANTED A ONE YEAR EXTENSION OF APPROVAL
TO EXISTING 510(K) REQUIREMENTS. THIS TERM OF APPROVAL, WHICH IS
LESS THAN THE NORMAL APPROVAL TERM, IS GIVEN IN ORDER TO PERMIT OMB
AND THE PUBLIC TO ASSESS FDA PROGRESS IN REDUCING 510(K)
BURDENS.
Inventory as of this Action
Requested
Previously Approved
07/31/1984
07/31/1984
04/30/1983
4,000
0
3,000
64,000
0
48,000
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.