CFR

CFR

SUBPART A—General Provisions (§803.1 to §803.19)

803.1—What does this part cover?
803.3—How does FDA define the terms used in this part?
803.9—What information from the reports do we disclose to the public?
803.10—Generally, what are the reporting requirements that apply to me?
803.11—What form should I use to submit reports of individual adverse events and where do I obtain these forms?
803.12—Where and how do I submit reports and additional information?
803.13—Do I need to submit reports in English?
803.14—How do I submit a report electronically?
803.15—How will I know if you require more information about my medical device report?
803.16—When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
803.17—What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
803.18—What are the requirements for establishing and maintaining MDR files or records that apply to me?
803.19—Are there exemptions, variances, or alternative forms of adverse event reporting requirements?

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