OTC Hearing Aids Final Rule - New Requirements

Medical Device Labeling Regulations; Unique Device Identification

OMB: 0910-0485

IC ID: 255349

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

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OTC Hearing Aids Final Rule - New Requirements
 
No Unchanged
 
Mandatory
 
21 CFR 800, 801, 808, 874  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance Guidance-PSAP-Hearing-Aid-Requirements AUG 2022.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

105 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 1,680 0 0 0 0 1,680
Annual IC Time Burden (Hours) 16,800 0 0 0 0 16,800
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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