OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

Accessory classification de novo request

IC 221835 under ICR 202502-0910-003 · OMB 0910-0823.

Documents and Forms
Document Name
Document Type
Other-Guidance; Medical Device Acces
Other-Guidance; Medical Device Acces
Information Collection (IC) Details

View Information Collection (IC)

Accessory classification de novo request
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance; Medical Device Accessories – Describing Accessories and Classification Pathways 0910-0823_Medical Device Accessories Guidance.pdf https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways Yes No Printable Only

Health Consumer Health and Safety

 

15 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 15 0 0 0 0 15
Annual IC Time Burden (Hours) 600 0 0 0 0 600
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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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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