View Information Collection Request (ICR) Package
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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:
0910-0823
ICR Reference No:
202202-0910-002
Status:
Active
Previous ICR Reference No:
201908-0910-010
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Medical Device Accessories
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:
09/21/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/19/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2025
36 Months From Approved
09/30/2022
Responses
15
0
25
Time Burden (Hours)
600
0
1,000
Cost Burden (Dollars)
0
0
0
Abstract:
The guidance document “Medical Device Accessories--Describing Accessories and Classification Mechanisms for Accessory Types” encourages manufacturers and other parties to utilize the “de novo request” process defined in section 513(f)(2) of the FD&C Act to request risk-based classifications of new types of medical device accessories. This process provides a pathway to class I or class II classification for accessory devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. Under the de novo request process, manufacturers and other parties may submit a de novo requesting that FDA make a classification determination for the accessory device. The de novo must include a description of the device and detailed information and reasons for any recommended classification.
Authorizing Statute(s):
US Code:
21 USC 321
Name of Law: FD&C Act
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:
87 FR 14891
03/16/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 49850
08/12/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Accessory classification de novo request
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
15
25
0
0
-10
0
Annual Time Burden (Hours)
600
1,000
0
0
-400
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:
Based on an evaluation of the information collection, we have reduced the estimated number of existing requests from 15 to 10, and we have reduced the estimated number of new requests from 10 to 5. This adjustment results in an overall reduction to the information collection by 10 responses and 400 hours annually. We believe these adjustments more accurately reflect the current number of requests associated with medical device accessory classifications.
Annual Cost to Federal Government:
$5,624,500
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?
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:
08/19/2022
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