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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:
0910-0138
ICR Reference No:
201812-0910-009
Status:
Historical Active
Previous ICR Reference No:
201806-0910-010
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Reclassification Petitions for Medical Devices
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
02/01/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/30/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2022
36 Months From Approved
09/30/2021
Responses
6
0
6
Time Burden (Hours)
2,982
0
3,000
Cost Burden (Dollars)
0
0
0
Abstract:
This ICR collects information from medical device manufactures who wish to request reclassification of a medical device. A manufacturer may petition the Agency to reclassify a device. The reclassification procedures regulation requires a manufacturer to submit specific data when petitioning for reclassification. This includes both a "supplemental data sheet" (Form FDA 3427) and a "classification questionnaire" (Form FDA 3429). Each of these forms contains a series of questions concerning the safety and effectiveness of the device type. The regulation requires device manufacturers to provide, in a petition for device reclassification, specification of the type of device, a statement of the action requested, and a justification for the request to reclassify.
Authorizing Statute(s):
US Code:
21 USC 360 ( e) ( f )
US Code:
21 USC 360e (b)
US Code:
21 USC 360j(1)
US Code:
21 USC 360i(b)(1)(A)
US Code:
21 USC 360d(b)
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AH75
Final or interim final rulemaking
83 FR 64443
12/17/2018
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
79 FR 16252
03/25/2014
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 64443
12/17/2018
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Reclassification Petitions for Medical Devices
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
6
6
0
0
0
0
Annual Time Burden (Hours)
2,982
3,000
0
0
-18
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:
$1,561,716
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.
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:
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:
01/30/2019
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