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

Forms and Documents

Document Name	Status
Form 3419 Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting Form and Instruction	Modified
eMDR draft guidance.doc Supplementary Document	2009-09-05
SS- 0910-0437 -REV. #13-10- 15-09.doc Supporting Statement A	2009-10-15

IC Document Collections

IC ID	Document Title	Status
6116	Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0437	ICR Reference No: 200909-0910-006
Status: Historical Inactive	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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 10/26/2009
	Date Received in OIRA: 09/17/2009
Terms of Clearance: OMB is filing comment on this ICR which is part of a proposed rule. Approval for the changes associated with the rule is not granted at this time. FDA should resubmit this ICR in conjunction with the final proposed rule.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2012	36 Months From Approved	08/31/2012
Responses	244,537	0	244,537
Time Burden (Hours)	294,194	0	294,194
Cost Burden (Dollars)	0	0	0

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Abstract: This proposal amends FDAs postmaket medical device reporting regulations to require that manufacturers, importers and user facilities submit mandatory reports of individual medical device adverse events ( MDRs) to the agency in an electronic fomat that FDA can process, review and achive.

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Authorizing Statute(s): US Code: 21 USC 360(a)(1) Name of Law: null
  

Citations for New Statutory Requirements: US Code: 21 USC 360(a)(1) Name of Law: null

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF86	Proposed rulemaking	74 FR 42203	08/21/2009

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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 Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting	3419, FDA 3500A	Medical Device Reporting Annual User Facility Report ,   Medical device Adverse Event Report

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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: Changing Forms

Short Statement: The burden decrease and cost increases are associated with the proposed rule to mandate electronic reporting of medical device adverse advents reporting. We estimate that the hourly burden will decrease because electronic reporting reduces industry`s time and cost associated with transcribing data from internal data management system to paper and mailing them to the agency. However respondents will incur an annualized capital/maintenance/operating costs of $373,871.

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Annual Cost to Federal Government: $2,200,000

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)? 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: 09/17/2009

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