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0910-0120 198304-0910-002
Historical Active 198101-0910-005
HHS/FDA
PREMARKET NOTIFICATION SUBMISSION
Revision of a currently approved collection   No
Regular
Approved without change 07/19/1983
Retrieve Notice of Action (NOA) 04/25/1983
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