Medical Device Labeling Regulations

Medical Device Labeling Regulations

OMB: 0910-0485

IC ID: 6187

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Medical Device Labeling Regulations
 
No Modified
 
Mandatory
 
21 CFR 800.10 (a)(3) 21 CFR 800.12(c) 21 CFR 800.10(b)(2) 21 CFR 801.1 21 CFR 801.5 21 CFR 801.61 21 CFR 801.62 21 CFR 801.109 21 CFR 801.110 21 CFR 801.150(e) 21 CFR 801.405(b)(1) 21 CFR 801.405(c) 21 CFR 801.420(c)(1&4) 21 CFR 800.421(b&c) 21 CFR 801.430(d) 21 CFR 430(e)(2) 21 CFR 801.430(f) 21 CFR 801.435(b,c & h) 21 CFR 809.10(a & b) 21 CFR 809.10(d)(1) 21 CFR 809.10(e) 21 CFR 809.10(f) 21 CFR 809.30(d) 21 CFR 801.150(a)(2) 21 CFR 801.410(e) 21 CFR 801.410(f) 21 CFR 801.421(d) 21 CFR 801.435(g)  (To search for a specific CFR, visit the Code of Federal Regulations.)

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

Health Consumer Health and Safety

 

92,419 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 2,386,987 0 0 66,602 0 2,320,385
Annual IC Time Burden (Hours) 3,620,102 0 0 116,982 0 3,503,120
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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