Reclassification Petitions for Medical Devices

Reclassification Petitions for Medical Devices

OMB: 0910-0138

IC ID: 5757

Information Collection (IC) Details

View Information Collection (IC)

Reclassification Petitions for Medical Devices
 
No Modified
 
Voluntary
 
21 CFR 860.123

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3429 General Device Classification Questionnaire Form FDA 3429.pdf Yes Yes Fillable Printable
Form and Instruction 3427 Supplemental Data Sheet Form FDA 3427.pdf Yes Yes Fillable Printable

Health Consumer Health and Safety

 

6 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 6 0 0 0 0 6
Annual IC Time Burden (Hours) 3,000 0 0 0 0 3,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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