Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0437
ICR Reference No:
201206-0910-003
Status:
Historical Active
Previous ICR Reference No:
200905-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting
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:
08/15/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/08/2012
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2015
36 Months From Approved
08/31/2012
Responses
374,090
0
244,537
Time Burden (Hours)
391,526
0
294,194
Cost Burden (Dollars)
0
0
0
Abstract:
Section 519(a), (b), and (c) of the Federal Food Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(a), (b), and (c)) requires user facilities, manufacturers, and importers of medical devices to report adverse events involving medical devices to the Food and Drug Administration (FDA). Information from these reports will be used to evaluate risks associated with medical devices and to enable FDA to take appropriate regulatory measures to protect the public health.
Authorizing Statute(s):
US Code:
21 USC 360(a)(1)
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
77 FR 8260
02/14/2012
30-day Notice:
Federal Register Citation:
Citation Date:
77 FR 33746
06/07/2012
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
Exemptions
Importer Reporting Malfunctions
Importer Reporting, Death and Serious Injury
MDR Files
MDR Procedures
Manufacturer Reporting
Supplemental Reports
User Facility Annual Reporting FDA Form 3419
3419
User Facility Annual Report Form
User Facility Reporting
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
374,090
244,537
0
0
129,553
0
Annual Time Burden (Hours)
391,526
294,194
0
0
97,332
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:
Annual Cost to Federal Government:
$5,660,064
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
Agency Contact:
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov
Common Form ICR:
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:
(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:
06/08/2012
An official website of the United States government
The .gov means it's official.
The site is secure.
