MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM

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
109712	MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM Form	Migrated

ICR Details

OMB Control No: 0910-0143	ICR Reference No: 198412-0910-007
Status: Historical Active	Previous ICR Reference No: 198312-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM
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: 03/12/1985
	Date Received in OIRA: 12/19/1984
Terms of Clearance: THIS INFORMATION COLLECTION APPROVED THROUGH 12/85. UPON RESUBMISSION FDA MUST SUBMIT A REPORT BASED UPON DATA COLLECTION THROUGH SEPT. 1985 DETAILING THE EXTENT TO WHICH THE DATA COLLECTED FROM THE DEN SYSTEM OVERLAPS AND DUPLICATES DATA RECEIVED UNDER THE MDR SYSTEM AND A COMPLETE EXPLANATION OF CORRECTIVE ACTIONS BASED SOLEY UPON DEN (AS OPPOSED TO MDR) REPORTS. FDA MUST SUBMIT EITHER 1) A PROPOSAL TO DISCONTINUE THE REPORTING SYSTEM OR 2) A PLAN TO MODIFY THE SYSTEM IN LIGHT OF THE FINDINGS IN THE REPORT ABOVE. ANY SUCH PLAN MUST CONTAIN SPECIFICATIONS FOR ALTERING THE CURRENT CONTRACT EFFECTIVE NOT LATER THAN APRIL 1, 1986.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/1986	12/31/1986	12/31/1984
Responses	2,500	0	2,400
Time Burden (Hours)	750	0	600
Cost Burden (Dollars)	0	0	0

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Abstract: THIS PROGRAM IS FDA'S PRIMARY SOURCE OF INCIDENT DATA CONCERNING THE SAFETY AND EFFECTIVENESS OF MEDICAL DEVICES. HEALTH CARE PROFESSIONAL (PHYSICIANS, NURSES, ETC.) USE THIS FORM TO VOLUNTARILY REPORT DEATHS, INJURIES, HAZARDS, AND OTHER DEVICE PROBLEMS. THESE REPORTS A USED TO HELP FDA PROTECT THE PUBLIC HEALTH VIA COMPLIANCE AND USER EDUCATION.

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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
MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM	FDA 2519F

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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	2,500	2,400	0	0	100	0
Annual Time Burden (Hours)	750	600	0	0	150	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: 12/19/1984

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