Medical Devices; Device Tracking

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0442_Supporting Statement_2021.pdf	Supporting Statement A	Uploaded 2021-02-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6125	Discontinuation of business		Removed
245903	Medical Device Tracking - Third-Party Disclosure		New
245900	Medical Device Tracking - Recordkeeping		New
245899	Medical Device Tracking - Reporting		New
214455	Multiple distributor data and distributor tracking records		Removed
214453	Acquisition of tracked devices and final distributor data		Removed
214432	Multiple distributor data and distributor tracking records		Removed
214431	Manufacturer data audit		Removed
214430	Standard operating procedures		Removed
214429	Record of tracking data		Removed
214428	Tracking information		Removed
214427	Multiple distributor data		Removed
214426	Notification of failure to comply		Removed
214425	Exemption or variance		Removed

ICR Details

OMB Control No: 0910-0442	ICR Reference No: 202101-0910-009
Status: Historical Active	Previous ICR Reference No: 201801-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Device Tracking
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 with change	Conclusion Date: 03/26/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/19/2021
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2024	36 Months From Approved	03/31/2021
Responses	613,736	0	613,736
Time Burden (Hours)	615,380	0	615,380
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from device manufactures and distributors who are subject to the requirements for device tracking, tracking systems, and distributor reporting. Manufacturers must track a class II or class III device if its failure would be reasonable likely to have serious adverse health consequences, or it is intended to be implanted in the human body for more than one year, or it is life-sustaining or life-supporting and used outside a device user facility, or when FDA determines that tracking would be appropriate in order to protect the general public in the event of a device recall.

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Authorizing Statute(s): US Code: 21 USC 360(e)(2)
   US Code: 21 USC 360(e)(1)
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 70634	11/05/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 9514	02/16/2021
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Acquisition of tracked devices and final distributor data
Discontinuation of business
Exemption or variance
Manufacturer data audit
Medical Device Tracking - Recordkeeping
Medical Device Tracking - Reporting
Medical Device Tracking - Third-Party Disclosure
Multiple distributor data
Multiple distributor data and distributor tracking records
Multiple distributor data and distributor tracking records
Notification of failure to comply
Record of tracking data
Standard operating procedures
Tracking information

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ICR Summary of Burden

table that charts list 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	613,736	613,736	0	-613,736	613,736	0
Annual Time Burden (Hours)	615,380	615,380	0	-615,380	615,380	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This information collection is being submitted with no changes or adjustments. The ICs in ROCIS have been consolidated from 11 to 3 to make it easier for review in the system.

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Annual Cost to Federal Government: $17,755

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 02/19/2021

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