21 CFR Part 803 · Medical Device Reporting

§ 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report?

Subpart E - Manufacturer Reporting Requirements Official text on eCFR Amendment history

You must submit a 5-day report to us with the information required by § 803.52 in accordance with the requirements of § 803.12(a) no later than 5 work days after the day that you become aware that:

(a) An MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. You may become aware of the need for remedial action from any information, including any trend analysis or

(b) We have made a written request for the submission of a 5-day report. If you receive such a written request from us, you must submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. We may extend the time period stated in the original written request if we determine it is in the interest of the public health.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 803.53

Form FDA 483 observations citing this section, fiscal years 2012–2019 (Devices).

Failure to Submit 5 Day Report 5

Warning letters citing § 803.53

1 FDA warning letters since 2017 cite this section :

Innova Medical Group, Inc. 10 Jun 2021

FDA guidance that cites § 803.53

Amendment history

Federal Register documents that created or amended this section.

79 FR 8846 14 Feb 2014

Form 483 citations

FY2012 FY2019

FDA Data Dashboard. Not every inspection is included, and an observation is not a final agency finding of a violation.

Ask Compliome

Get a cited answer that links this text to FDA, EU, UK and ICH requirements, enforcement and guidance.

“What does 21 CFR 803.53 (If I am a manufacturer, in which circumstances must I submit a 5-day report?) require, and what do FDA inspectors most often cite under it?”

Ask this question

Cross-references

§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports?

Part 803

← § 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports?
§ 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?
All sections of Part 803