Medical Device Reporting

ICR 201805-0910-006

OMB: 0910-0437

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0437 201805-0910-006
Active 201508-0910-002
HHS/FDA CDRH
Medical Device Reporting
Revision of a currently approved collection   No
Regular
Approved with change 08/08/2018
Retrieve Notice of Action (NOA) 06/21/2018
  Inventory as of this Action Requested Previously Approved
08/31/2021 36 Months From Approved 12/31/2018
563,827 0 361,185
67,978 0 46,446
0 0 0

This ICR collects information from medical device manufacturers, importers, and user facilities that are required to submit electronic and paper medical device reports (MDRs) to the Food and Drug Administration (FDA) and to maintain records, and who may also seek exemption from these requirements. The information that is obtained from these reports will be used to evaluate risks associated with medical devices and enable FDA to take appropriate regulatory measures to protect the public health. Complete, accurate, and timely adverse event information is necessary for the identification of emerging device problems so the Agency can protect the public health under the FD&C Act.

US Code: 21 USC 360i(a)(b)(c) Name of Law: FFDCA
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  82 FR 60922 12/26/2017
83 FR 26694 06/08/2018
Yes

  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 563,827 361,185 0 0 202,642 0
Annual Time Burden (Hours) 67,978 46,446 0 0 21,532 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We request revision of this ICR to add the reporting burden for the proposed Voluntary Malfunction Summary Report Program and to make the resulting revisions to the estimated burdens for Manufacturer Reporting and Supplemental Reporting, respectively. The adjustments to update the estimates based on CY 2016 data and the proposed revisions to OMB control number 0910-0437 together would increase the total estimated reporting burden by 21,532 hours.

$7,894,341
No
    Yes
    Yes
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.
06/21/2018


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