Postmarket Surveillance of Medical Devices

ICR 201309-0910-003

OMB: 0910-0449

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-09-03
ICR Details
0910-0449 201309-0910-003
Historical Active 201004-0910-007
HHS/FDA 20463
Postmarket Surveillance of Medical Devices
Extension without change of a currently approved collection   No
Regular
Approved without change 10/23/2013
Retrieve Notice of Action (NOA) 09/12/2013
  Inventory as of this Action Requested Previously Approved
10/31/2016 36 Months From Approved 10/31/2013
1,160 0 157
37,945 0 5,175
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

  78 FR 28853 06/16/2013
78 FR 55723 09/11/2013
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 1,160 157 0 0 1,003 0
Annual Time Burden (Hours) 37,945 5,175 0 0 32,770 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The number of submitters for all the ICs, except Waivers under section 822.29, has increased since the last information collection approval. In one case, both the number of submitters and the number of times per year that they send the information increased (Periodic reports (822.32). This adjustment in burden is based on the data available in FDA's internal tracking system.

$628,896
No
No
No
No
No
Uncollected
JonnaLynn Capezzuto 301 827-4659 [email protected]

  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.
09/12/2013


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