OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

De Novo requests

IC 227824 under ICR 202404-0910-004 · OMB 0910-0844.

Documents and Forms
Document Name
Document Type
Other-De Novo Classification Process
Other-Acceptance Review for De Novo
Other-Electronic Submission Template
Information Collection (IC) Details

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) 0844_De Novo Classification Process (Evaluation of Automatic Class III Designation).pdf Yes No Printable Only
Other-Acceptance Review for De Novo Classification Requests 0844_Acceptance Review for De Novo Classification Requests.pdf Yes No Printable Only
Other-Electronic Submission Template for Medical Device De Novo Requests 0844_Electronic Submission Template for Medical Device De Novo Requests.pdf Yes No Printable Only

Health Consumer Health and Safety

 

79 0
   
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 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

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.