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Back  RFI # 984: Investigational Device

Formal vs. Informal Help Informal Formal


Donald Graves


The Investigational Device Exemption Number is reported in Loop 2300 REF segment at position #1800, using qualifier LX.
The Situational Rule states: "...When more than one IDE applies, they must be split into separate claims." This suggests that the 5010 837I TR3 allows only one Investigational Device Exemption Number reported per claim (per 2300 Loop). If that is true, why is the Segment Repeat set to 5 for this REF segment?

Submitter Assigned Keywords

IDE Investigational Device Exemption Number


Original Response Finalized (4/9/2010)- The workgroup has confirmed the business need for more than one Investigational Device Exemption (IDE) Number per claim and will resolve this need in a future version by moving the IDE Number to the line level with a repeat of 1.

Further Clarification Requested (4/15/2010) - Until then, 5010 claims must be split if more than one IDE number exists based on the situational rule.
Submission 3/8/2010
Status Date 5/21/2010
Status F - Final
Primary References
Document 005010X223
Set ID837
Segment Position1800
Segment IDREF
Industry NameInvestigational Device Exemption Number