Orthopaedic Device Manufacturers Have No Choice: Unique Device Identification Necessitates Immediate Response
FDA to finalize UDI ruling in late summer
CHAGRIN FALLS, Ohio, June 13, 2013 /PRNewswire/ — OMTEC(®), the 9th Annual Orthopaedic Manufacturing & Technology Exposition and Conference, reported that forthcoming Unique Device Identification (UDI) regulations will necessitate immediate response from industry participants throughout the entire supply chain.
The weight of the impending mandate was evidenced by robust attendance in a UDI compliance presentation by Karen Conway, Executive Director at GHX, and further buzz throughout educational sessions and the exhibit show floor. The new guidelines, expected to be finalized later this summer, will affect device companies and suppliers of all sizes.
Other pressing topics included those discussed by an FDA-focused Keynote Panel who offered perspective and solutions on getting business done in an increasingly-globally regulated industry. OMTEC participants were encouraged to leverage the resources and referral services provided by the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) in addition to contacting FDA directly.
The UDI and FDA presentations, as well as OMTEC 2014 updates, are available at www.omtecexpo.com.
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