Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H

Medical Devices; Humanitarian Use Devices

OMB: 0910-0332

IC ID: 5922

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Information Collection (IC) Details

View Information Collection (IC)

Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H
 
No Modified
 
Mandatory
 
21 CFR 814.102 21 CFR 814.104 21 CFR 814.106 21 CFR 814.108 21 CFR 814.116(e)(3) 21 CFR 814.124(b) 21 CFR 814.126(b)(1)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0332_Guidance.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

175 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 175 0 0 -17 0 192
Annual IC Time Burden (Hours) 16,739 0 0 -2,971 0 19,710
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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