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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:
202107-0910-003
Status:
Historical Active
Previous ICR Reference No:
201805-0910-006
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Medical Device 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:
08/31/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/29/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2024
36 Months From Approved
08/31/2021
Responses
2,130,285
0
563,827
Time Burden (Hours)
223,338
0
67,978
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 360i(a)(b)(c)
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Other Documents for OIRA Review
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
86 FR 22671
04/29/2021
30-day Notice:
Federal Register Citation:
Citation Date:
86 FR 40593
07/28/2021
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
10
IC Title
Form No.
Form Name
Exemptions
Importer Reporting, Death and Serious Injury - Reporting
Importer Reporting, Death and Serious Injury - Third-Party
MDR Files
MDR Procedures
Manufacturer Reporting
Supplemental Reports
User Facility Annual Reporting FDA Form 3419
Form FDA 3419
User Facility Reporting
Voluntary Malfunction Summary Reporting Program
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
2,130,285
563,827
0
0
1,566,458
0
Annual Time Burden (Hours)
223,338
67,978
0
0
155,360
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:
This information collection has been adjusted. There has been an increase of 155,360 total burden hours and a corresponding increase of 1,566,458 total annual responses. This increase corresponds with data obtained from our database. In June 2019, the FDA formally ended the Alternative Summary Reporting (ASR) Program and revoked all such exemptions. As a result, manufacturers for which ASR's exemptions were revoked were then required to start submitting individual reports for each device associated event. This has resulted in an increase of the number of submissions.
Annual Cost to Federal Government:
$7,109,802
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
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?
No
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@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:
07/29/2021
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