Premarket Notification Submission 510(k), Subpart E

Premarket Notification Submission 510(k), Subpart E

OMB: 0910-0120

IC ID: 5734

Information Collection (IC) Details

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Premarket Notification Submission 510(k), Subpart E
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 800.807.92 21 CFR 800.807.93 21 CFR 807 Subpart E 21 CFR 807.90 21 CFR 807.87

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3514 CDRH Premarket Review Coversheet 0120_Form_FDA-3514.pdf Yes Yes Fillable Fileable
Form and Instruction FDA 3541 Premarket Notification [510(K)] Status Request and Response 0120_Form_FDA-3541.pdf Yes Yes Fillable Fileable
Form and Instruction FDA 3654 Standards Data Report for 510(k)s 0120_Form_FDA-3654.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

8,999 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 8,999 0 0 -450 0 9,449
Annual IC Time Burden (Hours) 358,633 0 0 23,806 0 334,827
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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