PREMARKET NOTIFICATION SUBMISSION

ICR 198408-0910-008

OMB: 0910-0120

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
109638
Migrated
ICR Details
0910-0120 198408-0910-008
Historical Active 198304-0910-002
HHS/FDA
PREMARKET NOTIFICATION SUBMISSION
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 10/31/1984
Retrieve Notice of Action (NOA) 08/06/1984
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.

None
None


No

1
IC Title Form No. Form Name
PREMARKET NOTIFICATION SUBMISSION

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 5,000 0 0 0 5,000 0
Annual Time Burden (Hours) 76,000 0 0 0 76,000 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

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.
08/06/1984


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