IMDRF Draft Guidance Comment Form UDI WG (PD1)/N48 - Unique Device Identification system (UDI system) Application Guide Date Document AIM North America 10/12/18 IMDRF UDI Guidance Document Commenting Line Clause/ Type of COMMENTS PROPOSED CHANGE Organization number Subclause comment NOTE: Please identify the issue clearly as to why the comment NOTE: Please provide suggested change in order for comment to be OF IMDRF Figure/ should support a change to the guidance understood for discussion (General, Technical. Editorial) AIM North Page Section Technical When a device must bear a UDI direct marking, Encourage both, but if have constraints, use America 11 4.0 | the UDI may be provided through either or both AIDC mark. Bullet 2 of the following: (1) easily readable plain-text or Following the human factors recommendations of (2) automatic identification and data capture ANSI/AAMI HE75:2009(R2013) for medical (AIDC) technology, or any alternative technology devices, fonts shall with a minimum point size of that will provide the UDI of the device on 5.5 (Note: 1 point = 1/72”). Sans serif fonts are demand. 3) When space is a limitation, machine recommended to be used. readable UDI symbol is preferred. 4) It is recommended that sans serif fonts be used Note: AIM NA, at the request of the FDA, had a meeting to discuss print quality, verification, and validation. During this meeting, AIM NA noted that image recognition is not widely used and not fully developed. Thus recommend the UDI be conveyed via scannable codes due to the robustness built into the standards. AIM North Page Section Technical Direct mark example should be changed to data America 13 6.2 matrix code mark
IMDRF Draft Guidance Comment Form UDI WG (PD1)/N48 - Unique Device Identification system (UDI system) Application Guide Date Document 10/12/18 IMDRF UDI Guidance Document AIM North America Commenting Organization Line number Clause/ Subclause Figure/ Type of comment (General, Technical. Editorial) COMMENTS NOTE: Please identify the issue clearly as to why the comment should support a change to the guidance PROPOSED CHANGE NOTE: Please provide suggested change in order for comment to be understood for discussion OF IMDRF AIM North America Page 11 Section 4.0 | Bullet 2 Technical When a device must bear a UDI direct marking, the UDI may be provided through either or both of the following: (1) easily readable plain-text or (2) automatic identification and data capture (AIDC) technology, or any alternative technology that will provide the UDI of the device on demand. 3) When space is a limitation, machine readable UDI symbol is preferred. 4) It is recommended that sans serif fonts be used Note: AIM NA, at the request of the FDA, had a meeting to discuss print quality, verification, and validation. During this meeting, AIM NA noted that image recognition is not widely used and not fully developed. Thus recommend the UDI be conveyed via scannable codes due to the robustness built into the standards. Encourage both, but if have constraints, use AIDC mark. Following the human factors recommendations of ANSI/AAMI HE75:2009(R2013) for medical devices, fonts shall with a minimum point size of 5.5 (Note: 1 point = 1/72”). Sans serif fonts are recommended to be used. AIM North America Page 13 Section 6.2 Technical Direct mark example should be changed to data matrix code mark
aim_na_comments_to_imdrf_udi_system_docs_for_public_consultation.docx