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 Yes Yes Fillable Fileable
Form and Instruction FDA 3514 Yes Yes Fillable Fileable
Form and Instruction FDA 4062 Yes Yes Fillable Fileable Signable
Form and Instruction FDA 4078 Yes Yes Fillable Fileable Signable
Other-Guidance; Recognition and Withdrawal of Voluntary Consensus Standards https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards Yes No Printable Only
Other-Guidance; Refuse to Accept Policy for 510(k)s https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks?utm_source=chatgpt.com Yes Yes Printable Only
Other-eSTAR for summary test reports and data elements Yes Yes Fillable Fileable Signable
Other-Guidance; Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-fall-within-enforcement-policies-issued-during-coronavirus-disease Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

16,295 1,050
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested 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 16,295 0 0 3,625 0 12,670
Annual IC Time Burden (Hours) 469,183 0 0 145,804 0 323,379
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.
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