Retail exemption for prescription devices--801.110

Medical Device Labeling Regulations

OMB: 0910-0485

IC ID: 214596

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Retail exemption for prescription devices--801.110
No New
21 CFR 801.110

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety


30,000 0
Private Sector Businesses or other for-profits
   5 %

  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 20,010,000 0 20,010,000 0 0 0
Annual IC Time Burden (Hours) 5,002,500 0 5,002,500 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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