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
109846	MEDICAL DEVICE REPORTING Form	Migrated

ICR Details

OMB Control No: 0910-0201	ICR Reference No: 199010-0910-003
Status: Historical Active	Previous ICR Reference No: 198905-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: MEDICAL DEVICE REPORTING
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/11/1991
	Date Received in OIRA: 10/17/1990
Terms of Clearance: This information collection is approved for use until June 30, 1992. In response to the previous terms of clearance in November 1988, FDA has stated it is conducting an 'in-depth' analysis of the MDR regulation to determine what types of changes may be necessary (e.g., the elimination of the 5 day reporting requirment). FDA also must now revise the MDR regulation to incorporate the requirement of the Safe Medical Devices Act of 1990. Taking these factors into consideration, OMB approves this package for 18 months. Upon its next submission, however, FDA will have completed its analysis of how the MDR regulation shouldlbe revised, including the new legislative requirements. In considering these revisions, FDA should determine whether rulemaking is necessary to revise reporting requirements to include the ARP policy and the criteria for granting such designation. OMB will not approve this information collection for use beyond June 1992 unless FDA has submitted to OMB an NPRM to revise the MDR regulations pursuant to the statutory deadline established by the Safe Medical Devices Act of 1990.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/1992	06/30/1992
Responses	925	0	0
Time Burden (Hours)	59,540	0	0
Cost Burden (Dollars)	0	0	0

---

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.

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
MEDICAL DEVICE REPORTING	FDA 3322

---

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	925	0	0	0	925	0
Annual Time Burden (Hours)	59,540	0	0	0	59,540	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:

---

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

---

Common Form ICR:  No

---

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: 10/17/1990

---