21 CFR Subpart E - Subpart E—Manufacturer Reporting Requirements
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- § 803.50 If I am a manufacturer, what reporting requirements apply to me?
- § 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports?
- § 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report?
- § 803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
- § 803.58 Foreign manufacturers.