Postmarket Surveillance of Medical Devices

ICR 201608-0910-014

OMB: 0910-0449

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-09-08
ICR Details
0910-0449 201608-0910-014
Historical Active 201309-0910-003
HHS/FDA CDRH
Postmarket Surveillance of Medical Devices
Extension without change of a currently approved collection   No
Regular
Approved without change 12/06/2016
Retrieve Notice of Action (NOA) 09/09/2016
  Inventory as of this Action Requested Previously Approved
12/31/2019 36 Months From Approved 12/31/2016
1,160 0 1,160
37,945 0 37,945
0 0 0

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.

US Code: 21 USC 522 Name of Law: null
  
None

Not associated with rulemaking

  81 FR 25409 04/28/2016
81 FR 62142 09/08/2016
No

  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
No
No

$850,461
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
09/09/2016


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