Medical Device Recall Authority

Forms and Documents

Document Name	Status
0432_Supporting Statement_2018.doc Supporting Statement A	2018-08-20

IC Document Collections

IC ID	Document Title	Status
6106	Collections Specified in the Order--810.10(d)	Unchanged
202312	Notification of Consignees by Recipients--810.15(e)	Unchanged
202311	Notification to Recipients; Follow-up--810.15(d)	Unchanged
202310	Notification to Recipients--810.15(a)-(c)	Unchanged
202309	Documentation of Notifications to Recipients--810.15(b)	Unchanged
202308	Termination Request--810.17(a)	Unchanged
202307	Periodic Status Reports--810.16(a-b)	Unchanged
202306	Mandatory Recall Strategy--810.14	Unchanged
202305	Written Request for Review--810.12(a-b)	Unchanged
202300	Request for Regulatory Hearing--810.11(a)	Unchanged

ICR Details

OMB Control No: 0910-0432	ICR Reference No: 201806-0910-011
Status: Active	Previous ICR Reference No: 201505-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Recall Authority
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: 09/19/2018
	Date Received in OIRA: 08/20/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2021	36 Months From Approved	09/30/2018
Responses	48	0	48
Time Burden (Hours)	1,090	0	1,090
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from manufacturers, importers, distributors, and retailers of medical devices to provide information, requests, or reports related to mandatory recall. The primary use of the information disclosed to FDA is to ensure that all devices entering the market are safe and effective, to accurately and immediately detect serious problems with medical devices, and to remove dangerous and defective devices from the market. A firm may initiate a voluntary recall of a violative device without FDA intervention. However, if FDA determines that such a voluntary recall is not effective in remedying a violation and there remains a reasonable probability that the violative device would cause serious adverse health consequences or death, FDA will invoke the medical device recall authority in addition to the voluntary efforts that the manufacturer has already undertaken.

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Authorizing Statute(s): US Code: 21 USC 360h Name of Law: null
  

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:
	83 FR 7740	02/22/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 38151	08/03/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Mandatory Recall Strategy--810.14
Collections Specified in the Order--810.10(d)
Request for Regulatory Hearing--810.11(a)
Written Request for Review--810.12(a-b)
Periodic Status Reports--810.16(a-b)
Termination Request--810.17(a)
Documentation of Notifications to Recipients--810.15(b)
Notification to Recipients; Follow-up--810.15(d)
Notification of Consignees by Recipients--810.15(e)
Notification to Recipients--810.15(a)-(c)

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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	48	48	0	0	0	0
Annual Time Burden (Hours)	1,090	1,090	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: $292,383

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? 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: 08/20/2018

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