New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data)

Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

OMB: 0910-0616

IC ID: 214356

Information Collection (IC) Details

View Information Collection (IC)

New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data) CBER
 
No Removed
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA 3674 Certification of Compliance FORM FDA 3674 12-19-14.pdf Yes Yes Fillable Fileable Signable
Other-Guidance FINAL GUIDANCE 0616 12-19-14.pdf Yes No Paper Only

Health Consumer Health and Safety

 

530 0
   
Private Sector Businesses or other for-profits, Not-for-profit institutions
 
   70 %

  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 0 0 0 -530 0 530
Annual IC Time Burden (Hours) 0 0 0 -398 0 398
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.

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