Annual Reporting for Custom Device Exemption

ICR 202008-0910-011

OMB: 0910-0767

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-08-31
IC Document Collections
IC ID
Document
Title
Status
211453 Modified
ICR Details
0910-0767 202008-0910-011
Active 201706-0910-009
HHS/FDA CDRH
Annual Reporting for Custom Device Exemption
Extension without change of a currently approved collection   No
Regular
Approved without change 10/02/2020
Retrieve Notice of Action (NOA) 08/31/2020
  Inventory as of this Action Requested Previously Approved
10/31/2023 36 Months From Approved 10/31/2020
34 0 33
1,360 0 1,320
0 0 0

This ICR collects information from manufacturers of custom devices through submission of an annual report to FDA that identifies the number of new custom devices unit manufactured and distributed per year. Based on the information provided in the annual report, FDA will determine whether a device continues to meet the qualifications for a custom device exemption. Also, the annual reports will allow FDA to assess several important issues related to the description and use of the custom device in patients and physicians. As a result, manufacturers developing a custom device for a product not generally available in the United States and meet the requirements defined in section 520(b) of FD&C Act, will be required to develop and submit an annual report for the maximum five units per year of a particular device type.

PL: Pub.L. 112 - 144 617 Name of Law: FDASIA
  
None

Not associated with rulemaking

  85 FR 10175 02/21/2020
85 FR 41593 07/10/2020
No

1
IC Title Form No. Form Name
Annual Report for Custom Devices

  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 34 33 0 0 1 0
Annual Time Burden (Hours) 1,360 1,320 0 0 40 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects adjustment. We have increased the number of respondents from 33 to 34 to reflect more recent data.

$0
No
    No
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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.
08/31/2020


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