View Information Collection (IC)
View Information Collection (IC)

View Information Collection (IC)

Premarket Notification Submissions
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 807, subpart E (807.81-807.100  (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
Form FDA 3881 Indications for Use FDA-3881.pdf Yes Yes Fillable Fileable
Form and Instruction FDA 3514 CDRH Premarket Review Submission Cover Sheet FDA-3514.pdf Yes Yes Fillable Fileable
Form and Instruction FDA 4062 electronic Submission Template and Resource (eSTAR) eSTAR (static) FDA 4062.pdf Yes Yes Fillable Fileable Signable
Form and Instruction FDA 4078 IVD electronic Submission Template and Resource (eSTAR) IVD eSTAR (static) FDA 4078.pdf Yes Yes Fillable Fileable Signable
Other-guidance Recognition of Standards and Withdrawal.docx Yes No Printable Only
Other-guidance RTA guidance.pdf Yes Yes Printable Only
Other-eSTAR for summary test reports and data elements 0120_ASCA STR format.docx Yes Yes Fillable Fileable Signable
Other-Agency Guidance COVID-Transition-Enforcement-Guidance MARCH 2023.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

3,800 1,050
   
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 12,670 0 0 3,671 0 8,999
Annual IC Time Burden (Hours) 323,379 0 0 4,210 0 319,169
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.