Medical Devices: Current Good Manufacturing Practice (CGMP), Quality System (Q/S) Regulation; 21 CFR Part 820

Medical Devices: Current Good Manufacturing Practice (CGMP), Quality System (Q/S) Regulation; 21 CFR Part 820

OMB: 0910-0073

IC ID: 5714

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Medical Devices: Current Good Manufacturing Practice (CGMP), Quality System (Q/S) Regulation; 21 CFR Part 820
 
No Migrated
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability


    

9,229 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 1 0 0 -7,236 0 7,237
Annual IC Time Burden (Hours) 3,167,670 0 0 -735,499 0 3,903,169
Annual IC Cost Burden (Dollars) 1,182,000 0 0 -27,080,000 0 28,262,000

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