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

View Information Collection (IC)

De Novo requests
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 860.210 21 CFR 860.220

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-De Novo Classification Process (Evaluation of Automatic Class III Designation) Yes No Printable Only
Other-Acceptance Review for De Novo Classification Requests Yes No Printable Only
Other-Electronic Submission Template for Medical Device De Novo Requests Yes No Printable Only

Health Consumer Health and Safety

 

79 0
   
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 79 0 0 11 0 68
Annual IC Time Burden (Hours) 14,378 0 0 2,002 0 12,376
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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