Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))

Forms and Documents

Document Name	Status
Form FDA 3670 Adverse Event Reporting Form and Instruction	Modified
0471 ss Part B 4-17-14.doc Supporting Statement B	2014-04-17
0471 ss Part A 4-17-14.doc Supporting Statement A	2014-04-17

IC Document Collections

IC ID	Document Title	Status
37668	Adverse Event Reporting Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0471	ICR Reference No: 201404-0910-011
Status: Historical Active	Previous ICR Reference No: 201110-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/23/2014
	Date Received in OIRA: 04/22/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved	05/31/2014
Responses	3,750	0	6,000
Time Burden (Hours)	2,813	0	4,500
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information for the Food and Drug Administration's Medical Product Safety Network (MedSun) program from a subset of medical device user facilities that constitutes a representative profile of user reports for device-related deaths and serious injuries related to medical devices. FDA relies on reports of product problems from consumers and health care professionals, as well as from device manufacturers, in order to understand if signals of product problems are emerging in the postmarket use environment. MedSun is a significant, and very successful, strategy used by FDA to understand problems with medical devices in use in hospitals and outpatient services associated with hospitals. The MedSun program is unique to FDA and provides FDA with the ability to have a dialogue with the clinical community, so they may work together to learn about, understand, and solve problems with the use of medical devices.

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Authorizing Statute(s): US Code: 21 USC 360 Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 71620	11/29/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 20887	04/14/2014
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
Adverse Event Reporting	FDA 3670, FDA 3670, FDA 3670, FDA 3670, FDA 3670, FDA 3670	MedSun Database Additional Questions ,   MedSun Database Contact Screen ,   MedSun Database Device Screen ,   MedSun Database Event Screen ,   MedSun Database Patient Screen ,   MedSun Database Test Screen

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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	3,750	6,000	0	0	-2,250	0
Annual Time Burden (Hours)	2,813	4,500	0	0	-1,687	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: We have updated the title of this collection to reflect that the program is no longer in its pilot phase. We have estimated a reduced number of respondents (formerly 400, now 250) because we have determined that number to provide a roughly representative sample of small, medium, and large hospitals across the country (see further explanation in part B.1 of this supporting statement) and because we are currently receiving more reports than we can manage given our current resources. This adjustment has resulted in a decrease of 1,687 burden hours.

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Annual Cost to Federal Government: $3,500,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 04/22/2014

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