Medical Devices; Humanitarian Use Devices

ICR 202101-0910-008

OMB: 0910-0332

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-02-24
IC Document Collections
ICR Details
0910-0332 202101-0910-008
Received in OIRA 201912-0910-006
HHS/FDA CDRH
Medical Devices; Humanitarian Use Devices
Revision of a currently approved collection   No
Regular 02/24/2021
  Requested Previously Approved
36 Months From Approved 03/31/2021
213 175
22,542 16,739
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

  85 FR 49379 08/13/2020
86 FR 11303 02/24/2021
No

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

  Total Request 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 213 175 0 0 38 0
Annual Time Burden (Hours) 22,542 16,739 0 0 5,803 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have also updated the burden estimate consistent with new provisions in §814.104(b)(4)(i)) regarding “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices” (83 FR 7366; February 21, 2018) (approved under OMB control number 0910-0741). Section 814.104 is being amended to address submission of data from clinical investigations in a Humanitarian Device Exemption (HDE). To the extent the applicant includes data from clinical investigations, the applicant will be required to include the information and statements as described in § 814.104(b)(4)(i). Consistent with our estimate in OMB control number 0910-0741, this revision increases our burden estimate for a Humanitarian Device Exemption (HDE) by 8 hours per submission. These adjustments have resulted in an overall increase of 5,803 hours to the total estimated burden.

$5,924,835
No
    Yes
    No
No
No
No
No
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.
02/24/2021


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