§ 803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms?

(a) If you are a manufacturer or importer, you must submit reports of individual adverse events to FDA in an electronic format in accordance with § 803.12(a) and § 803.20 , unless granted an exemption under § 803.19 .

(b) Importer reports submitted to device manufacturers may be in paper format or an electronic format that includes all required data fields to ensure that the manufacturer has all required information.

(c) If you are a user facility, you must submit reports of individual adverse events in accordance with § 803.12(b) and § 803.20 .

(d) Form FDA 3500A is available on the internet at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm .

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What FDA inspectors cite under § 803.11

Form FDA 483 observations citing this section, fiscal years 2009–2016 (Devices).

• Failure to use FDA Form 3500A 3

Warning letters citing § 803.11

2 FDA warning letters since 2017 cite this section :

• DRG Instruments GmbH 31 Mar 2025
• TELEMED 14 Nov 2017

FDA guidance that cites § 803.11

• Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff 8 Nov 2016
• Medical Device Reporting for User Facilities 1 Apr 1996

Amendment history

Federal Register documents that created or amended this section.

• 79 FR 8846 14 Feb 2014
• 80 FR 10587 27 Feb 2015
• 85 FR 18441 2 Apr 2020