Regulatory Open Forum

​​Hello RAPS members,

Definition of accidental radiation occurence, ARO, at CFR is pretty vague.
So it's hard to determine when to report, and difficult to distinguish with MDR and safety related defect in 21 CFR 1003.2.
Does anyone have guidance how to determine ARO?

1000.3 (a) Accidental radiation occurrence  means a single event or series of events that has/have resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a result of the manufacturing, testing, or use of an electronic product.

Thanks in advance.

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Jeongpyo Hong
Sr. Professional, Regulatory Affairs
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Hi,

I thought I replied to this post , not sure if it remained a draft ..

Sec. 1002.20 Reporting of accidental radiation occurrences.
(c) If a manufacturer is required to report to the Director under paragraph (a) of this section and also is required to report under part 803 of this chapter, the manufacturer shall report in accordance with part 803. If a manufacturer is required to report to the Director under paragraph (a) of this section and is not required to report under part 803, the manufacturer shall report in accordance with paragraph (a) of this section. A manufacturer need not file a separate report under this section if an incident involving an accidental radiation occurrence is associated with a defect or noncompliance and is reported pursuant to 1003.10 of this chapter.
 
I was in the same position as you are 3 years ago , and I checked with the FDA  'for medical device manufacturers, probably at least 95% of the radiation-type adverse events you are made aware of would qualify as an MDR reportable event.  I think the few device AROs we see are due to malfunctions and incidents experienced during service procedures that don't rise to the MDR reporting threshold.  However, for nonmedical electronic product manufacturers, all their adverse events that could cause injuries would be reportable AROs.   

So what we do is assess  the risk , if its unacceptable , then we report under the 803 ( I also report under the 1003 as well , although its not mandatory) and such instances  would usually be accompanied by a defect so we report the correction under 1004. Else for acceptable risk where the radiation is determined at an acceptable MPE level , then report under the 1002.

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RashmiGreenacresAustralia
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Original Message:
Sent: 05-Mar-2020 01:36
From: Jeongpyo Hong
Subject: ARO guidance

​​Hello RAPS members,

Definition of accidental radiation occurence, ARO, at CFR is pretty vague.
So it's hard to determine when to report, and difficult to distinguish with MDR and safety related defect in 21 CFR 1003.2.
Does anyone have guidance how to determine ARO?

1000.3 (a) Accidental radiation occurrence  means a single event or series of events that has/have resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a result of the manufacturing, testing, or use of an electronic product.

Thanks in advance.

------------------------------
Jeongpyo Hong
Sr. Professional, Regulatory Affairs
------------------------------