Medical Devices; Humanitarian Use Devices

ICR 201912-0910-006

OMB: 0910-0332

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2019-12-16
Supporting Statement A
2018-01-18
IC Document Collections
ICR Details
0910-0332 201912-0910-006
Active 201801-0910-003
HHS/FDA CDRH
Medical Devices; Humanitarian Use Devices
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/30/2019
Retrieve Notice of Action (NOA) 12/16/2019
  Inventory as of this Action Requested Previously Approved
03/31/2021 03/31/2021 03/31/2021
175 0 175
16,739 0 16,739
0 0 0

This ICR collects information from manufactures who wish to obtain "Humanitarian Use Device" (HUD) designation for a medical device and marketing approval for the HUD notwithstanding the absence of reasonable assurance of effectiveness that would otherwise be required. To the extent consistent with the protection of the public health and safety and with ethical standards, this program encourages the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in fewer than 4,000 individuals in the United States per year. Obtaining marketing approval for a HUD involves two steps: (1) Obtaining designation of the device as a HUD from FDA's Office of Orphan Products Development and (2) submitting a Humanitarian Device Exemption (HDE) application to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), or the Center for Drug Evaluation and Research (CDER), as applicable. A person granted an exemption must submit periodic reports.

US Code: 21 USC 360(d) Name of Law: null
   US Code: 21 USC 360(e) Name of Law: null
  
None

Not associated with rulemaking

  82 FR 48096 10/16/2017
83 FR 1263 01/10/2018
No

1
IC Title Form No. Form Name
Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H

  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 175 175 0 0 0 0
Annual Time Burden (Hours) 16,739 16,739 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$6,903,000
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@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.
12/16/2019


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