Reporting- FDAAA, section 512A(a)(2)-Description of Any Pediatric Subpopulation That Suffers From Disease That The Device is Intended to Treat Diagnose or Cure.

Guidance: Humanitarian Device Exemption Regulation: Questions and Answers

OMB: 0910-0661

IC ID: 192258

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Other-Guidance - Questions and Answe
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Reporting- FDAAA, section 512A(a)(2)-Description of Any Pediatric Subpopulation That Suffers From Disease That The Device is Intended to Treat Diagnose or Cure.
 
No New
 
Required to Obtain or Retain Benefits
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance - Questions and Answers Guidance - HDE-Questions and Answers.doc Yes No Printable Only

Health Consumer Health and Safety

 

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Private Sector Businesses or other for-profits
 
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  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 5 5 0 0 0 0
Annual IC Time Burden (Hours) 500 500 0 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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