CDRH 513(g) Requests

Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0705

IC ID: 197892

Documents and Forms
Information Collection (IC) Details

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CDRH 513(g) Requests
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-513g Guidance Document guidance 513(g) Requests.pdf http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209841.htm Yes No Printable Only

Health Public Health Monitoring

 

114 0
   
Private Sector Businesses or other for-profits, Not-for-profit institutions
 
   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 114 0 0 0 0 114
Annual IC Time Burden (Hours) 1,368 0 0 0 0 1,368
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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