Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting

Forms and Documents

Document	Type	Status	Availability
Form 3419 User Facility Annual Reporting FDA Form 3419	Form and Instruction	New	Available
0437--MDR--supporting statement.doc	Supporting Statement A	Uploaded 2012-06-07	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6116	Manufacturer Reporting		Modified
202637	Importer Reporting Malfunctions		New
202636	MDR Files		New
202635	MDR Procedures		New
202634	Supplemental Reports		New
202633	Importer Reporting, Death and Serious Injury		New
202632	User Facility Annual Reporting FDA Form 3419	Form and Instruction	New
202631	User Facility Reporting		New
202630	Exemptions		New

ICR Details

OMB Control No: 0910-0437	ICR Reference No: 201206-0910-003
Status: Historical Active	Previous ICR Reference No: 200905-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting
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: 08/15/2012
	Date Received in OIRA: 06/08/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved	08/31/2012
Responses	374,090	0	244,537
Time Burden (Hours)	391,526	0	294,194
Cost Burden (Dollars)	0	0	0

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Abstract: Section 519(a), (b), and (c) of the Federal Food Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(a), (b), and (c)) requires user facilities, manufacturers, and importers of medical devices to report adverse events involving medical devices to the Food and Drug Administration (FDA). Information from these reports will be used to evaluate risks associated with medical devices and to enable FDA to take appropriate regulatory measures to protect the public health.

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Authorizing Statute(s): US Code: 21 USC 360(a)(1) 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:
	77 FR 8260	02/14/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 33746	06/07/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Manufacturer Reporting
Exemptions
User Facility Reporting
User Facility Annual Reporting FDA Form 3419	3419	User Facility Annual Report Form
Importer Reporting, Death and Serious Injury
Supplemental Reports
MDR Procedures
MDR Files
Importer Reporting Malfunctions

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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	374,090	244,537	0	0	129,553	0
Annual Time Burden (Hours)	391,526	294,194	0	0	97,332	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: $5,660,064

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]? 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: 06/08/2012

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