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Medical Devices
Recent Blogs
LexisNexis Reed Tech teams up with RegDesk, a leading regulatory information management platform
Horsham, Pa., USA – May 25, 2023The collaboration of the leading providers of Unique Device Identification (UDI) for...
Coffee Talk with Reed Tech – EU EUDAMED Testing Update
In the latest edition of 'Coffee Talk', Reed Tech UDI experts, Gary Saner (Sr. Manager of Information Solutions) and...
Simplifying Annual Drug Sample Reporting
Pharma manufacturers and authorized distributors need to submit distribution reports electronically in an eXtensible Markup Language (XML) format to comply with the guidance entitled Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act. This guidance fulfills the Drug Sample Transparency Act specification of ACA Section 6004. These amounts must be reported each year by April 1st for the previous calendar year.
MoCRA: The Future of Cosmetic Regulations
The Modernization of Cosmetics Regulation Act of 2022 overhauls existing regulations, mandating FDA-established Good Manufacturing Practices for cosmetics manufacturers.
Medical Device Regulatory Requirements – Japanese Guidelines
This is a quick summary of the December 14, 2022 Emergo Webinar presented by Kenji Yashiro on the topic: Medical...
Class I UDI Inventory Exception: What You Need to Know about FDA Compliance
In 2013, the FDA granted a UDI exception for 3 years after the corresponding Compliance Date for finished medical devices manufactured and labeled without Unique Device Identification (UDI) as of the Compliance Date, commonly referred to as the 3-Year Inventory UDI Exception or the ‘Final Rule.’ Such devices meeting the criteria could be commercially distributed for 3 years after the corresponding Compliance Date without complying with UDI requirements. At the end of the 3-year period, any undistributed inventory would need to be reprocessed to comply with current UDI requirements, i.e., UDI Label and GUDID reporting.
Vision Expo West and Eyewear Industry UDI
Reed Tech Life Sciences representative Patti Shragher attended The Vision Expo West 2022 conference, on...
Combination Products: Regulatory Requirements and How To Comply
Continue to be at the forefront of regulatory chatter. Our customers, both primarily medical device and primarily pharmaceutical, are regularly coming to us with questions surrounding this topic. Reed Tech answers these questions here in this blog post