Kum 20 13 khan Food and Drug Administration (FDA) chuan dan hnuhnung ber a tichhuak a, chu chuan device identification system danglam tak a siam a, chu chu distribution leh use hmanga devices te chu a dik taka hriat theihna tura duan a ni. Rule hnuhnung ber chuan device labeller-te chuan device label leh package-ah unique device identifier (UDI) an dah tel tur a ni a, chu chu rule-in exception emaw alternative emaw a pekna hmun tih loh chu. UDI tin hi plain-text version leh automatic identification and data capture (AIDC) technology hmanga siam tur a ni. UDI hi vawi khat aia tam hman tur device-ah direct-a mark a ngai bawk ang a, hman apiangin reprocess tura ruahman a ni bawk ang. Device label leh package-a date awmte chu international standard leh international practice nena inmil standard format-a tarlan tur a ni.
UDI chu numeric emaw alphanumeric code danglam tak a ni a, a then hnih a awm a:
device identifier (DI), UDI-a labeler leh device pakhat version emaw model bik hriat theihna tur mandatory, fixed portion, leh
production identifier (PI), UDI-a conditional, variable portion, device label-a dah a nih chuan a hnuaia mi pakhat emaw a aia tam emaw hriat theihna:
device siamna lot emaw batch number emaw;
device bik pakhat serial number;
device bik pakhat expiry date;
hmanrua bik siam ni;
mihring cell, tissue, emaw cellular leh tissue-based product (HCT/P) device anga regulated tana §1271.290(c)-in a phut identification code danglam tak chu.
UDI zawng zawng hi FDA-accredited issuing agency-in a enkawl system hnuaia pek chhuah tur a ni. Rule hian diltuin FDA accreditation a dil theihna tur process a pe a, diltuin FDA hnena a pek tur information a tarlang a, dilna endikna atana FDA-in a hman tur criteria a tarlang bawk.
Exception leh alternative thenkhat chu dan hnuhnung berah tarlan a ni a, chu chuan senso leh phurrit chu a tlem berah dah a ni. UDI system hi stage hrang hrangah hman tan a ni ang a, kum sarih chhungin hman tan a ni ang a, hei hi a taka kalpui a nih theih nan leh a kalpui dan tur senso leh phurrit te chu vawi khata lakluh vek ngai lovin, hun kal zelah a darh zel theih nan a ni ang.
He system kalpui mek zingah hian device labelers te hian FDA enkawl Global Unique Device Identification Database (GUDID)-ah information an thehlut tur a ni. GUDID hian UDI nei device tinte tana basic identifying elements standard set a keng tel ang a, DI CHAUH a awm ang a, chu chu database-a device information hmuh theihna tur key atan a thawk ang. PI te hi GUDID ah hian an tel lo.
FDA hian heng thu tam zawk hi AccessGUDID-ah mipui hnenah a pe chhuak a, National Library of Medicine nena thawhhona hmangin a siam a ni. Medical device hmangtute chuan AccessGUDID hmangin device chungchanga information an zawng thei a, an download thei bawk. UDI hian device hmangtu chungchang, mimal privacy information te pawh tiamin, a tarlang lo va, GUDID database-ah pawh a awm lo vang.
GUDID leh UDI chungchang hriat belh duh chuan UDI Resources page en la, chutah chuan education module angkai tak tak, kaihhruaina, leh UDI nena inzawm thil dangte link i hmu ang.
'labeler' chu device pakhata label vuah tir, emaw, device label tihdanglam tirtu, device chu a hnu lama label thlak leh siam danglam ngai lovin sumdawnna atana sem chhuah a nih tumna a ni. Device semtu hming leh a biak theihna tur information dah belh chu, label-a tihdanglamna dang siam lovin, mi pakhat chu labeler a nih leh nih loh hriatna atana siam danglamna a ni lo. A tam zawkah chuan labeler chu device siamtu a ni ang a, mahse labeler chu specification developer, single-use device reprocessor, convenience kit assembler, repackager emaw relabeler emaw a ni thei.
Automatic identification and data capture (AIDC) tih hian UDI emaw device identifier emaw chu automated process hmanga electronic patient record emaw computer system dang emaw-a dah theih tur angin a thlen thei technology eng pawh a huam a ni.
