Postmarket Surveillance of Medical Devices

Forms and Documents

Document Name	Status
0449_Supporting Statement.doc Supporting Statement A	2016-09-08

IC Document Collections

IC ID	Document Title	Status
6135	Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports	Modified
192723	Recordkeeping Postmarket Surveillance of Medical Devices: manufacturer and investigator records	Modified

ICR Details

OMB Control No: 0910-0449	ICR Reference No: 201608-0910-014
Status: Historical Active	Previous ICR Reference No: 201309-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Postmarket Surveillance of Medical Devices
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: 12/06/2016
	Date Received in OIRA: 09/09/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2019	36 Months From Approved	12/31/2016
Responses	1,160	0	1,160
Time Burden (Hours)	37,945	0	37,945
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from manufacturers who are required to conduct postmarket surveillance of a medical device that meets the criteria set forth in the statute. The postmarket surveillance submission includes the postmarket plan, information about the person designated to conduct the surveillance, and organizational/administrative information. The information collection also includes the submission of changes to the plan, requests for a waiver of any requirement of the regulation, requests for exemption from the requirement to conduct postmarket surveillance, and submission of periodic reports as specified in the postmarket surveillance plan. Additionally, manufacturers and investigators must maintain records to ensure that the postmarket surveillance is conducted in accordance with the approved plan. The information collected and maintained enables FDA to ensure that the postmarket surveillance will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health.

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Authorizing Statute(s): US Code: 21 USC 522 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:
	81 FR 25409	04/28/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 62142	09/08/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports
Recordkeeping Postmarket Surveillance of Medical Devices: manufacturer and investigator records

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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	1,160	1,160	0	0	0	0
Annual Time Burden (Hours)	37,945	37,945	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: $850,461

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

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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: 09/09/2016

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