Unique Device Identification System

Forms and Documents

Document Name	Status
0720_Supporting Statement.doc Supporting Statement A	2016-12-29

IC Document Collections

IC ID	Document Title	Status
203301	Third-Party Disclosure (ongoing)	Modified
203300	Recordkeeping (ongoing)	Modified
203299	Reporting (ongoing)	Modified
203298	Third-Party Disclosure (Date Format)	Removed
203297	Third-Party Disclosure (UDI)	Removed
203296	Recordkeeping (first year)	Removed
203295	Reporting (first year)	Removed

ICR Details

OMB Control No: 0910-0720	ICR Reference No: 201612-0910-002
Status: Historical Active	Previous ICR Reference No: 201309-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Unique Device Identification System
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: 02/16/2017
	Date Received in OIRA: 12/30/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved	02/28/2017
Responses	926,823	0	1,830,553
Time Burden (Hours)	579,553	0	802,821
Cost Burden (Dollars)	0	0	0

---

Abstract: FDA is issuing regulations establishing a unique device identification system for medical devices. The recordkeeping, reporting, and third-party disclosure requirements referenced in the UDI regulation are imposed on any person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label. In most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler. This rule is intended to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use.

---

Authorizing Statute(s): US Code: 21 USC 360i(f) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 63768	09/16/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 94386	12/23/2016
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Third-Party Disclosure (Date Format)
Reporting (ongoing)
Recordkeeping (ongoing)
Third-Party Disclosure (ongoing)
Reporting (first year)
Recordkeeping (first year)
Third-Party Disclosure (UDI)

---

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	926,823	1,830,553	0	0	-903,730	0
Annual Time Burden (Hours)	579,553	802,821	0	0	-223,268	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: FDA adjusted the burden estimate by removing the 1st year burden estimates

---

Annual Cost to Federal Government: $1,800,000

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]? 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

---

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: 12/30/2016

---