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Federal forms, ICRs, and supporting documents

Information Collection

510(k) Third-Party Review Program

IC 6015 under ICR 202504-0910-003 · OMB 0910-0375.

Documents and Forms
Document Name
Document Type
Other-Guidance; 510(k) Third Party R
Other-Guidance; 510(k) Third Party R
Information Collection (IC) Details

View Information Collection (IC)

510(k) Third-Party Review Program CDRH
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance; 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review 0910-0375_Guidance; 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review.pdf https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergency-use-authorization-eua-review Yes No Printable Only

Health Consumer Health and Safety

 

41 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 275 0 0 0 0 275
Annual IC Time Burden (Hours) 6,439 0 0 15 0 6,424
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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