PREMARKET NOTIFICATION SUBMISSION

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
109637	PREMARKET NOTIFICATION SUBMISSION	Migrated

ICR Details

OMB Control No: 0910-0120	ICR Reference No: 198304-0910-002
Status: Historical Active	Previous ICR Reference No: 198101-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: PREMARKET NOTIFICATION SUBMISSION
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/19/1983
	Date Received in OIRA: 04/25/1983
Terms of Clearance: 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
Expiration Date	07/31/1984	07/31/1984	04/30/1983
Responses	4,000	0	3,000
Time Burden (Hours)	64,000	0	48,000
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
PREMARKET NOTIFICATION SUBMISSION

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ICR Summary of Burden

	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	4,000	3,000	0	0	1,000	0
Annual Time Burden (Hours)	64,000	48,000	0	0	16,000	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/25/1983

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