Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Disclosure; Importer Reporting, Death and Serious Injury Modified 148983 52144 0
Postmarketing Safety Reporting for Combination Products Unchanged 198 89 0
Recordkeeping; MDR Files--803.18 Modified 1871 2807 0
Recordkeeping; MDR Procedures--803.17 Modified 1871 6174 0
Reporting: Special controls: submission of complaint log; 866.3956(b)(1)(iii) and 866.3957(b)(1)(iii) Modified 10 30 0
Reporting; Exemptions--803.19 Modified 28 28 0
Reporting; Importer Reporting, Death and Serious Injury--803.40 and 803.42 Modified 148983 148983 0
Reporting; Manufacturer Reporting-- 803.50 through 803.53 Modified 2320393 232039 18710
Reporting; Supplemental Reports--803.56 Modified 1027591 102759 0
Reporting; User Facility Annual Reporting--803.33; FDA Form 3419 Modified 82 82 0
Reporting; User Facility Reporting-- 803.30 and 803.32 Modified 5621 1967 0
Reporting; Voluntary Malfunction Summary Reporting Program Modified 2503 250 0
Total burden requested under this ICR: 3658134 547352 18710  
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