Medical Devices: Medical Device Reporting, Certification and U.S.-Designated Agents

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
5711	Medical Devices: Medical Device Reporting, Certification and U.S.-Designated Agents Form	Migrated

ICR Details

OMB Control No: 0910-0059	ICR Reference No: 199607-0910-004
Status: Historical Inactive	Previous ICR Reference No: 199512-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices: Medical Device Reporting, Certification and U.S.-Designated Agents
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: 09/04/1996
	Date Received in OIRA: 07/26/1996
Terms of Clearance: OMB does not approve this revised package, although the MDR information collection provisions already approved under this OMB number may continue to be implemented. OMB is concerned that these revised reporting requirements may be overly burdensome and wishes to allow the private sector the opportunity to fully consider the newly proposed requirements. When the paperwork package is re-submitted for OMB approval at the final rule stage, the agency will directly address OMB's concerns and any public comments received on these issues in the preamble of the rule and in the paperwork submission package. With respect to the total estimated annual burden associated with this package, OMB carried forward the already approved burden numbers for the entire package approved on 02/23/96 and added one burden hour for these revised provisions, pending completion of the rulemaking process.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/1999	02/28/1999	02/28/1999
Responses	127,900	0	127,900
Time Burden (Hours)	188,110	0	0
Cost Burden (Dollars)	68,280,000	0	0

---

Abstract: This regulation requires medical device user facilities, manufacturers, and distributors to report deaths, serious injuries, and certain malfunctions related to medical devices. This proposal amends reporting requirements for device manufacturers and distributors re: the certification language and instructions approved under Information Collection 0910-0059.

---

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 Devices: Medical Device Reporting, Certification and U.S.-Designated Agents	FDA-3381

---

Burden increases because of Program Change due to Agency Discretion: Yes

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: 07/26/1996

---