MEDICAL DEVICE REPORTING

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
109845	MEDICAL DEVICE REPORTING Form	Migrated

ICR Details

OMB Control No: 0910-0201	ICR Reference No: 198808-0910-004
Status: Historical Active	Previous ICR Reference No: 198801-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: MEDICAL DEVICE 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: 11/21/1988
	Date Received in OIRA: 08/23/1988
Terms of Clearance: This information collection request is approved under the condition that FDA will submit a report with the next request for clearance that provides the following: 1) Analysis of all ARPs issued by that time - detailing the bases for their issuance and evaluating whether there are underlying generic changes in the reporting, 2) Analysis of all malfunction reports, particularly those that did not lead to any manufacturer or agency action, for trends and criteria that might eliminate unnecessary reporting, as part of this analysis FDA should identify whether the report was generated pursuant to a statement by a health care professional, 3) Assess whether HIMA's suggested criteria for determining when a malfunction is likely to occur would enhance malfunction reporting, or if some other additional criteria might improve the reporting, 4) a listing of actions taken pursuant to non-life-threatening 5-day reports prior to receipt of the 15-day follow-up reports. On the basis of the findings in this report FDA should re-evaluate whether rulemaking to revise the reporting requirements is appropriate

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/1990	05/31/1990	08/31/1988
Responses	17,598	0	17,598
Time Burden (Hours)	71,112	0	71,112
Cost Burden (Dollars)	0	0	0

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Abstract: THIS REGULATION REQUIRES A MANUFACTURER OR IMPORTER OF MEDICAL DEVICES TO REPORT TO FDA WHEN THEY POSSESS INFORMATION SUGGESTING A DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY, OR HAS MALFUNCTIONED AND IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. IMPORTERS ARE REQUIRED TO ESTABLISH AND MAINTAIN FILE OF REPORTS AND RECORDS.

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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 REPORTING	FDA 3322

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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	17,598	17,598	0	0	0	0
Annual Time Burden (Hours)	71,112	71,112	0	0	0	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: 08/23/1988

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