PREMARKET NOTIFICATION SUBMISSION (510(K))

Forms and Documents

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Collection	Type	Status	Form
109640	PREMARKET NOTIFICATION SUBMISSION (510(K))		Migrated

ICR Details

OMB Control No: 0910-0120	ICR Reference No: 198610-0910-008
Status: Historical Active	Previous ICR Reference No: 198503-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: PREMARKET NOTIFICATION SUBMISSION (510(K))
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: 01/21/1987
	Date Received in OIRA: 10/23/1986
Terms of Clearance: THIS INFORMATION COLLECTION IS APPROVED THROUGH 2/88. AS A CONDITION OF SUBSEQUENT APPROVAL FDA SHOULD SUBMIT A COMPLETE INFORMATION REQUES THAT INCLUDES A WRITTEN DESCRIPTION OF THE REVISED CRITERIA FOR THE WAIVER OF 510(k) NOTIFTION REQUIREMENTS AND A DISCUSSION OF ON GOING EFFORTS TO DEVELOP GUIDELINES FOR DEVICE OR CATEGORY SPECIFIC DATA SUBMISSION REQUIREMENTS.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/1988	02/28/1988	12/31/1986
Responses	5,000	0	5,000
Time Burden (Hours)	78,000	0	76,000
Cost Burden (Dollars)	0	0	0

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Abstract: MANUFACTURER'S WISHING TO DISTRIBUTE NE OR CHANGED MEDICAL DEVICES MUST SUBMIT A PREMARKET NOTIFICATION TO FDA 90 DAYS BEFORE MARKETING. FDA REVIEWS THE NOTIFICATION AND DETERMINES WHETHER THE PRODUCT IS SUBSTANTIALLY EQUIVALENT TO A PRE-AMENDMENTS DEVICE. THOSE WHICH ARE EQUIVALENT MAY BE MARKETED IMMEDIATELY, AND THOSE WHICH ARE NOT, MAY NOT BE MARKETED WITHOUT FURTHER EVALUATIO

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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 (510(K))

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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	5,000	5,000	0	0	0	0
Annual Time Burden (Hours)	78,000	76,000	0	0	2,000	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: 10/23/1986

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