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CDRH Accreditation Scheme for Conformity Assessment: reporting; recordkeeping; and disclosure elements

IC 240128 under ICR 202212-0910-012 · OMB 0910-0889.

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Other-Agency Guidance
Other-Agency Guidance
Other-Agency Guidance
Other-Agency Guidance
Other-Agency Guidance
Other-webform
Other-webform
Other-webform
Other-webform
Information Collection (IC) Details

View Information Collection (IC)

CDRH Accreditation Scheme for Conformity Assessment: reporting; recordkeeping; and disclosure elements
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance ASCA-Pilot-Guidance SEPT 2020.pdf Yes Yes Fillable Fileable
Other-Agency Guidance ASCA-Pilot-Biocompatibility-Guidance SEPT 2020.pdf Yes Yes Fillable Fileable
Other-Agency Guidance ASCA-Pilot-Standards-Safety-Guidance SEPT 2020.pdf Yes Yes Fillable Fileable
Other-webform ASCA STR format.pdf Yes Yes Fillable Fileable
Other-webform ASCA webform mockups.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

158 75
   
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 2,039 0 0 94 0 1,945
Annual IC Time Burden (Hours) 10,362 0 0 -3,129 0 13,491
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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