21 CFR 803.30: If I am a user facility, what reporting requirements apply to me?
User facilities must report device-related deaths to FDA and the manufacturer, and serious injuries to the manufacturer (or FDA if unknown), within 10 work days of awareness, including all reasonably known information.
Part 803, Medical Device Reporting · Subpart C, User Facility Reporting Requirements
How FDA words it
The opening lines investigators use most when they cite 803.30, from the 483s we hold.
The user facility did not submit FDA Form 3500A or electronic equivalent to the known device manufacturer within 10 working days of becoming aware of information that reasonably suggests that a device has or may have caused or…Most used
Recent 483s citing 803.30
- Virginia Mason Medical Center · Seattle, WashingtonThe user facility did not submit FDA Form 3500A or electronic equivalent to the… Apr 15, 2016
- Advocate Lutheran General Hospital · Park Ridge, IllinoisThe user facility did not submit FDA Form 3500A or eleclmnic equivalent to FDA and… Jan 11, 2016
- UCLA Ronald Reagan Medical Center · Los Angeles, CaliforniaThe user facility did not submit FDA Form 3500A or electronic equivalent to… Dec 18, 2015
- General Hospital Corporation · Boston, MassachusettsThe user facility did not submit FDA Form 3500A or electronic equivalent to FDA… Dec 18, 2015
- Dartmouth-Hitchcock Medical Center · Lebanon, New HampshireThe user facility did not submit FDA Form 3500A or electronic equivalent to the… Dec 17, 2015
The regulation text
§ 803.30 If I am a user facility, what reporting requirements apply to me?.
(a)You must submit reports to the manufacturer or to us, or both, as specified in paragraphs (a)(1) and (a)(2) of this section as follows:
(1)Reports of death. You must submit a report to us as soon as practicable but no more than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known. You must submit the information required by § 803.32. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12(b).
(2)Reports of serious injury. You must submit a report to the manufacturer of the device no later than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to us. You must report information required by § 803.32. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12 (b).
(b)What information does FDA consider “reasonably known” to me? You must submit all information required in this subpart C that is reasonably known to you. This information includes information found in documents that you possess and any information that becomes available as a result of reasonable followup within your facility. You are not required to evaluate or investigate the event by obtaining or evaluating information that you do not reasonably know.
Questions
What does 21 CFR 803.30 require?
User facilities must report device-related deaths to FDA and the manufacturer, and serious injuries to the manufacturer (or FDA if unknown), within 10 work days of awareness, including all reasonably known information.
How do FDA investigators word a 803.30 observation?
The most common opening is: “The user facility did not submit FDA Form 3500A or electronic equivalent to the known device manufacturer within 10 working days of becoming aware of information that reasonably suggests that a device has or may have caused or…”
Which sections are cited alongside 803.30?
In the same 483s, investigators most often also cite 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?), 803.32 (If I am a user facility, what information must I submit in my individual adverse event reports?).